Next Step (Date Unknown)

Today Saint H and I met with Dr. V of the radiation oncology team at Cleveland Clinic. He reviewed my scans and my medical history and has agreed to take me on as a patient, whoopee! He felt that I'm in good physical condition and "blooming" health, except for that little cancer problem, and that I'm a very good candidate for this treatment.

We're waiting into early next week to find out what kind of schedule we're looking at, but he wants to begin sometime next week. As he described the procedure, it's something like what was done for gamma knife, but we're looking for "gentle destruction" (his term) because lung tissue is so much more delicate than brain tissue. There are the usual times set up for mapping the lesion, and plotting the radiation plan, then I'll be scheduled for 10 sessions of radiation, 15 minutes each. In fact, I'll be getting radiation for as long as the gamma knife procedure took, just cautiously administered over 10 business days! There will be somewhat less concern over the precision aiming, though we'll be locking onto the target with what are known as "tattoos" resembling small dark moles on my chest. I suggested to him the concept of registration marks for printers, and he agreed with that. Potential side effects? I may develop some "sunburn" or darkening of the skin surface, and I may develop pneumonitis, irritation of the lung tissue resulting in coughing and shortness of breath. I don't cough now, and have only had shortness of breath when I exert myself on very, very warm, humid days, so perhaps it will take longer to see that develop. And, because the esophagus is so close to the radiation site for me, I may have some inflammation of the esophagus before this is over. Fortunately these are all controllable. This goes beyond palliative treatment; he expects to see the lesion completely destroyed, which will leave it to me and Dr. G to focus on treating the remaining lung lesions.

For the moment we don't know the schedule, because Dr. V has to coordinate several schedules - his own and the oncology team's, Dr. G's, and that of the American Cancer Society's Hope Lodge, Cleveland. Hope Lodge provides housing at no charge for cancer patients and their families when on extended stays in a distant city for treatment; with a 2-1/2 hour drive one way from home to Cleveland Clinic, I certainly qualify for the service. As you can see in this virtual tour, the facility is lovely.

The "no charge" option is becoming vital, though I can for the moment afford the Cleveland Clinic rate at the Doubletree Downtown, Lakeside ($89.00/night for rooms that normally rent for as much as $299.00/night). However, doing restaurant meals on top of about $1000 in hotel costs is getting outside my comfort zone financially. If I can take advantage of the Hope Lodge program and test out the lovely kitchens, I'll be pretty happy. We picked up a flyer on the surrounding area; lots to do to keep myself busy outside of my "15-minute day". Friend M can pursue some grant research that she needs to do, friend B has offered to be my keeper too, so Saint H won't have to be there the whole time.

The sooner I know the schedule and how it affects when I can start on Afinitor (and from that, what my schedule will be with Dr. G), the better I'll feel. Guess I'll start packing books and knitting now so I can be ready to go at a moment's notice. Some things are much more important than clothes ...

Keen-Eyed Man

I'm such a good, compliant patient! Much against my inclination I decided to go back on the full dose of Votrient after my stomach had stopped rebelling. I really wanted to cut back the dosage, but Dr. G overruled me. After I got over sniping about "Dr. God" I finally figured out that he was simply trying to remove the reaction to the sulfa drug from the equation, and his wishes actually made more sense than mine. And I'm happy to report that over a week has passed on the full dose and I have had no apparent side effects. If things go well I'll stay on it at least until the first set of scans next month. If, however, I develop the side effects again I'm sure he'll have no objection to cutting the dosage back somewhat.

I had some trouble sleeping earlier this week. One night I stayed awake until 5:00 a.m.; before I went off to bed I managed to drop my laptop edge-wise on my left big toe, leaving a big gash and a fabulous bruise. That was partway healed when, another morning, I had gotten up and settled on the couch to work on some documents. I stood up, my right foot buckled under me, and I fell, twisting my ankle. Thank goodness (in some ways) that I've much experience with that ankle - I've probably sprained it six times since I entered college, twice really badly, and I've broken it. I could tell that it wasn't broken, and I had all the goods to alleviate my situation - I just wrapped it and elevated it, put cold compresses on it, and clumped around in my airboot (from the break in 2001). It's still sore after 5 days but I can walk almost normally. I suspect that my balance has suffered over the years, or else I've become sensitive about falling after repeated episodes; I find that I'm just not as steady on my feet as I used to be. I guess I can live with it as long as the damage isn't too severe.

Last week my brother P got a big surprise - he found a downed weather balloon in a field across from the house. He called the number listed and received a visit from some very excited University of Illinois students who came to retrieve it. You may enjoy the pictures taken by the balloon's camera on its short flight. The boys refer to the "keen-eyed man in IN" who found the balloon. I think it's more the case that P, like Saint H, is so familiar with his environment that he notices things; he doesn't necessarily have to "see" things to register a difference in his mind. Since he refused a reward the boys brought him a "Chief Illini" statue as a thank-you; I'll look forward to seeing it when we go visit next month.

Actually, Mr. Yuk Is My Enemy

I sent a message to Dr. G and Nurse Shari last night. I'd spent that truly miserable week with nausea and vomiting, though never so bad as when I was on Sutent, and had to finally give up on the sulfa drug rather than spend all my time in bed or the bathroom. Some of the nausea and stomach upset persisted until early Sunday morning, by which time I felt so rotten that I curled up in bed and stayed there quite late. When I got up I was still so woozy that I just couldn't face eating or taking my dose of Votrient, so I didn't take it.

Surprisingly, within a couple of hours my stomach had calmed, and the weird swallowing problem I've had for over a month had gone away. My appetite returned, and I was feeling pretty fabulous for the first time in a long time. It's funny how it's borne in on one, by the absence of symptoms, how quickly one can feel better - the misery becomes a distant memory in no time.

So, I thought I needed some advice from my medical professionals - should we consider lowering the Votrient dose? How much of this could be blamed on the nasty sulfa drug? Was it possible for symptoms to disappear so quickly, or was I just so relieved to feel better that I was hallucinating? Would they condone lowering the dose or would they want me to stick it out until my first scan in June?

I called Nurse Shari in midmorning as I'd not heard from her. Turns out Dr. G isn't due in until later today, but she was able to give me the following tidbits:
- The nausea and vomiting was almost without doubt due to the sulfa drug, as it's notorious for causing severe stomach distress. I should add it to my no-no list and forbid any doctor from giving it to me again (my inclination exactly, and thank goodness there was no hesitation on that decision)
- The remaining symptoms are probably due to the Votrient and she suspects we will reduce the dosage level. All I have to do is wait for Dr. G to arrive and have time to decide course of action with her, and they'll relay to me.

I really enjoy participating to this level in my own care - perhaps it's perverse in some people's view, but good heavens! I feel like I have some control over what's happening. Why persist in misery just because "that's what I was told to do"? That may have been the traditional approach to medical treatment ("Sit quietly and take the nice medicine, that's a good girl!") but I certainly have no use for it.

I am thrilled to report that, after several years, barn swallows have located one of the brackets Saint H placed on the internal fascia of the front porch. They are placing a careful array of mud pellets for a nest, right in view of the living room window. Cola is absolutely fascinated. Our house is becoming a handy roosting spot for the barn swallows; this morning I was serenaded by a throng of them waking up from roosting on the roof. A raucus symphony, indeed, but one of the most welcome sounds I can think of.

Normalcy?

Well, I'm back in my own shoes, wearing regular socks, and requiring nothing more drastic than an occasional slathering of lotion to keep the skin on my legs and feet supple. The edema finally responded to slow, steady use of a diuretic, and I'm pleased to put my ugly shoes away for the next time. It's such a relief to abandon yet more medicine, and to see results that require only patience and time.

Actually, I so seldom "see" results that I hardly know what to think. We in the Renal Cell group always kid one another: If you've got side effects, your meds must be working, unless the side effects get out of control to the extent that one must stop taking the medication! But side effects are generally the only outward sign of a medication's "presence" in the body. I have to rely on scans and test results to know how things are going, and even then I'm at the mercy of someone else's interpretation of those results - I can't make any judgement for myself by looking at the test results, or viewing the scans. Fortunately we have tools at our disposal.

I mentioned long ago a great resource, Netwellness, which is a service of 3 major universities in Ohio for composite medical information that's unbiased and definitive. One of the most useful components of that service is the Medline Plus Medical Encyclopedia, where one can look up test names to see what the test is measuring, what's "normal" and what the test results indicate. All of the Medline Plus content is available without charge to anyone with an internet connection; there are lots of ways to get to the Medline Plus site but I like to recommend Netwellness because of the other resources available there.

Saint H got a nasty surprise yesterday. After suffering all weekend with a mild toothache that gradually worsened, he ended up in the dentist's office yesterday afternoon, getting a crown. Further, he's scheduled for another appointment tomorrow morning for a crown on the tooth next to the one treated yesterday. Ah, the wonder of growing older - I know it's worth keeping one's own teeth as long as possible, but egads it can be costly! Guess we'll cross that bridge when we come to it.

First Day

We went to Cleveland for appointments on Friday - benchmark scans and a general check on my health and well-being. And, because I was still dealing with edema in my lower legs and feet, I had ultrasound exams on both legs. Our results were good: scans were stable and lab results were generally in good shape, though my hemoglobin levels are down to 8.7 from 11.4 at the last set of labs. The ultrasounds were added to the mix late in the day, so we didn't have final results when we left. By the end of the day I had my first 30-day supply of Votrient with instructions to begin on Monday if all the test results were good.

I spent much of the weekend stewing about the possibilities: side effects, my body's weaknesses and strengths, warning signs, and the like. Even though I had come to a decision, that decision once made must still be lived with. Without data to fold into the equation, one's mind becomes the hamster, endlessly chasing the "what if"s through the night on the treadmill of the unknown.

I did query my friend Bruce who started on Votrient about 3 weeks ago; we've gone through Sutent and Nexavar together, with some of the same reactions to the same drugs. I was reassured to hear from him that it's gone well; I can't tell you how much that calmed my fears.

Monday I saw my primary care physician Dr. MC to reassess my current maintenance meds; we changed out one blood pressure med for another, and reconfirmed my use of a diuretic to continue fighting the edema. Then I called Dr. G's office; Nurse Shari and I traded phone calls for a while until we finally talked together in late afternoon. The ultrasounds showed no blood clots so I was given the go-ahead to start on Votrient today.

I took a full dose, 800 mg, at 10:30 this morning. The day passed relatively normally (a meeting, lunch, and a lecture tonight) and I'm feeling relieved. So far so good; no immediate negative response, no big red flags. I'll be watching things closely, monitoring my blood pressure and looking for signs of trouble. Keeping fingers crossed - would love to have a med without side effects! What a concept!

Seventy-five Bucks Worth of Butt-Ugly

I mentioned that I've (probably) developed pitting edema; we're still exploring what this all means. For the past 10 days or so I've been hobbling around on horrifically painful feet, with not a single pair of my own shoes or boots fitting over stiff, swollen feet that look like turtle flippers. I can't bend my feet enough to slide into a shoe. Add to that the problem of socks that bind, and one is guaranteed to face misery anytime one's feet hit the floor. So I'd solved the problem the same way that I did once before, by stealing a pair of Saint H's size 9 lace-ups. I'm glad to see that some innovations, such as so-called "diabetic socks" are showing up in quantities enough that one isn't forced to go to a specialty store to find them (and they really do seem to work).

I'd suggested that Saint H might want to invest in a pair of hard-soled slippers that I could borrow as needed. Off we went to our local discount shoe store; I found nothing of that nature that would fit me. When the clerk began asking him more questions, I told her it was my problem, not his; and she shifted gears without a hitch and brought several candidate shoes to me. Of one, she said, "It's ugly but it's comfortable."

That's how I managed to come out of the shoe store with a pair of velcroed walkers with absolutely no pressure points. They're black, they're men's size 8.5 EE, and I can't imagine actually wanting to own this pair of shoes. Once again, though, my comfort is more important than my vanity, and that $75 might just be the best money I've spent for a while! It's much more important to be mobile than fashionable!

All-Nighters

I've had lots of near-sleepless nights since the gamma knife procedure. That's due in part to the steroids, I know, but I've had a lot to think about since the middle of February.

When we left Cleveland Clinic on March 1, we had information on 4 drugs, a rough idea of schedule needs, and an assignment: choose the next drug I wanted to use by the end of the week. You may be wondering what goes into making such a decision, and I can tell you it's not easy. The four drugs we were looking at were: Votrient, Torisel, Avastin, and Afinitor. Here are some of the factors we considered:

Schedule - How quickly can one begin a new therapy? What might influence the schedule?

Risks - All of the drugs involve varying types of risk, though certainly better odds than doing nothing. Of the four, which posed the most immediate threat to me based on my individual response to the drugs I've taken so far?

Efficacy - What's the drug's mechanism of action and track record to date? Is it similar to drugs I've already taken, or is it something new that we'll have to monitor closely?

Side effects - Are the side effects controllable with other medications? Is there evidence of any new or particularly threatening side effect that I haven't encountered with other drugs?

Costs - What is the drug's cost? How much will insurance pay? How much will I pay out-of-pocket?

Other considerations - Are there some inherent constraints that will control access, schedule or other points on the list?

Taking these factors, we came up with the following concerns:
Schedule - In this case, Dr. G wanted me to start as soon as I could, possibly by March 8. The problem: steroids would preclude concurrent use of two of the four drugs, and my late-night driving adventure spelled the need for continued steroid use; therefore all four drugs return to the list of possibles. My start date: on or about my next appointment, April 2

Risks - Risk assessment is the hardest part of the equation and is closely tied to the drug's efficacy and side effects. Each person's reaction to a drug is very individualized. So, while I know that VEGF-inhibitors may increase one's risk for internal bleeding, not all VEGF-inhibitors cause me to bleed (so far only Sutent holds that distinction). Newly approved drugs try another approach, with a new drug pathway to try, the mTor inhibitor. My leaning is to exhaust all the drugs of a single class before trying something new; hence my inclination to go with Votrient first. But the most serious side effect of Votrient is the potential for liver failure, and given the liver damage I already have, this gives me pause.

Costs - I'm very lucky; these drugs are horrendously expensive and all require a "pharmacy override". That is, I must use my drug plan's special pharmacy service so that the cost benefits are spread over the entire pool, or else I must pay a good portion out-of-pocket. Heck, yes, I'll let them mail the drug to me and pay my normal co-pay.

Other considerations - Oral drugs can be mailed directly to me; drugs requiring an infusion (in this case, Torisel and Avastin) would be administratively harder to deal with. With infusions, the hospital or facility administering the drug probably would have to receive the drug. Would it go to their pharmacy, in which case would I have to pay more for it? It's not a scenario I'd like to test out just now.

So, my choice became "an oral VEGF-inhibitor", which leaves me with Votrient. As we don't have any idea how my body will react to a new drug, I'll be "baby-sat" off and on while I adjust to the medication and dosage level. I'll probably be traveling to Columbus during the day, sitting and knitting at C2's house. That way should I develop any problems I'm 10 minutes away from the OSU Medical Center, as opposed to being 20 minutes from the nearest hospital here and over an hour from the OSU Medical Center.

There you have it - a breakdown of what is, in essence, a life-and-death decision. It's not something to be taken lightly, but we can certainly weigh all the factors as part of the whole. Given enough information, I can analyze just about anything, I believe, and come up with a decision that I'm happy with.

I'm happy to say that my diaper rash has finally cleared up. Now I've got pitting edema in my lower legs. What I've read isn't encouraging but at least we're doing what we can to combat it. Will be interested to see what Dr. G wants to do when we go up on Friday.

Cleanup On Aisle Two

I have always thought myself to be fairly modest and retiring. It runs in the family, but I do know that we've gotten a lot more vocal about our health since my diagnosis.

I hope nobody is offended by this post but it's something that I've had to deal with a lot since 2000. When one is dealing with chronic illness, there are often daily complications that may be - shall we say - indelicate? Following my liver resection, I wore an abscess drain for 8 months and had an open wound that took seven months of daily cleaning and bandaging by my dearest Saint H, sometimes as often as three times a day. While taking Sutent, I couldn't keep food down and often had to leave the table during dinner, leaving my friends to wait for me; waitresses and other restaurant diners probably thought I was drunk or something because I was in the bathroom vomiting so much. And I can't even imagine the number of medical folks whose eyes have travelled over all this battered scenery through the years.

After a while I got used to the idea that my modesty isn't as important as my comfort. Right now I'm dealing with thick and acrid bowel movements that have blistered the skin on my butt. I don't know whether it's to do with the steroids or whether it's a purge of the clinical trial drug (I do have nearly a year's worth of that in my system, after all), but I hope that this stops soon. I've been flagging poor Saint H a couple of times a day to check out how the blisters look. And, as I didn't have kids and didn't babysit, I didn't have a clue about what to do.

Fortunately friend/sister C2 is a successful aunt to multiple nieces and nephews, and her years of diapering experience gave me relief. Yep, I figure I've got a bad case of diaper rash, and Desitin is my friend.

The next time I hear some poor sodden child wailing in a public space before a diaper is changed, I won't stop my ears; I will feel and understand your pain.

Night Rider

Yesterday I finally got a long-overdue haircut in Columbus - 3 weeks past cut is a terrible time to endure with short hair. I had lunch with friends and sisters C2 and Monka, visited with them, and then went off to the Renal Cell Networking Group meeting. Saint H and I decided to dine afterwards (I am, after all, ravenous) before driving home, so we adjourned to a nearby restaurant.

My troubles began as I drove toward the restaurant. There's a not-so-well-marked left turn into the restaurant, and a not-so-obvious exit beyond the restaurant. I got into the left-turn lane and then realized that I couldn't see anything against the glare of oncoming lights. I thought I saw the left turn and there was a break in the oncoming stream of light, so I turned.

I'd missed the turn and instead bucked the poor Subaru up over the barrier for the exit, driving the wrong way over the curb. I managed to keep control of the car, and was able to maneuver around to park safely without scaring myself any further.

When I left for home I realized that my visual acuity was almost nil: I could tell that there was a difference between light and dark to my right, but I couldn't focus my right eye and I couldn't distinguish between lights, buildings, and signs. All were just simple blobs of light, and I couldn't tell what was moving and what wasn't. I had a hair-raising 40-mile drive home - thank goodness I'm familiar with the roads and could stay out of most people's way.

Given all the information from Dr. Sam C on the affected brain sectors, I suspected that there was swelling affecting the visual cortex. As instructed, I reported in today! I fired off an email to Dr. G and called Dr. LA's office as Dr. G is out of the office for a few days. Dr. LA's office increased the steroid dose for today and they'll give me further instructions tomorrow.

I may end up in Columbus tomorrow at one of the Cleveland Clinic remote facilities for a scan. In the meantime we had to shuttle a car to the mechanic tonight; short drive on home roads, and at least I could tell what was moving and what was stationary. I'm not planning to drive at night again anytime soon.

Going Forward

At long last we've gotten through 2009, a fairly miserable year for so many people that I hope we never see its equal. On the whole I feel I got through it with few scrapes, and I know I'm lucky.

We were in Cleveland for evaluations on December 30, and I'm stable still, so we are moving forward with Cycle 7 of the clinical trial. The worst side effect continues to be fatigue - I'm tempted to say "the only side effect" but I don't know that for certain. I do know that this drug seems to be tolerated well by participants, from the scanty reports I've heard. The company was able to get the full complement of trial patients for the study. That's a pretty good mark on its own; many trials run into trouble amassing the target study group, whether that's due to stringent prerequisites for participation, or adverse reactions leading to patient dropouts.

During December I started having pain between my right scapula and my spine - nothing drastic, but a fairly constant dull ache. The pain felt very much like pressure on a nerve, similar to what I'd experienced in 2004 while recovering from my liver resection. At that time I developed an abscess that extended from my liver to mid-back behind the right lung, and I was in constant pain from it. Only after we discovered and drained the abscess did I get relief.

For this round I jokingly suggested that it might be my cooking habits - maybe I was straining a muscle while chopping vegetables? I asked Dr. G to review my November C/T scans with me prior to my second treatment in the cycle; even though I'd joked about my cooking habits I had in fact altered my kitchen setup, but there was no change in the pain or its location. We moved through frame by frame and discovered that the tumor in my right lung is now pressing against one of my ribs, and that appears to be the cause of my discomfort.

So what does that mean? I feel better knowing what the problem is, and we're in no hurry to take me off the trial - Dr. G still refers to it as my "body vacation" from other treatments. We may reassess my pain medication, though for now my regular routine is enough to keep it at bay. We may look more closely down the road at some type of Gamma knife or Novalis procedure.

We continue to have options, even beyond available therapies. I'm so very glad to have such good teams to work with.

Kick In The Teeth

Well, crap. Last week, insurance paperwork, billings and all from the first of the year finally worked all the way through the mill and I sent off the usual $900+ check to Cleveland Clinic to settle my annual out-of-pocket requirements. Hooray, no more unknowns, just the usual copays, prescriptions and incidentals for the rest of the year.

But wait! Yesterday I went to the dentist for a regularly-scheduled cleaning, and we found yet another cracked tooth. The rear right lower molar has cracks in all four directions, plus a couple of chips, plus decay along the edge of a filling that went in about 3 years ago. That's 3 cracked teeth in the last 2 years, folks. Some of my other teeth are now developing chips on their cutting edges, too. And the remedy for a cracked tooth, of course, is another crown. Crap!!!

Vivian asked, "Do you grind your teeth?" "No, I don't think so ..." "Well, what about dry mouth from your medications?" Oh, yes, indeed - what about dry mouth?

Dr. K doesn't think that there have been any studies about the relation between dry mouth, cancer medications, and dental problems. I'm ready to believe it, though - I have always taken care of my teeth, and I'm stunned by the amount of dental work I've had to go through in the last 3 years. Saliva acts as a lubricant, and without it the teeth bang against each other - grinding without grinding, as it were.

My schedule stinks, as does my bank account; I'm going to put off getting the crown as long as I can. For now I've got a prescription toothpaste, Colgate PreviDent 5000 Dry Mouth, Biotene mouthwash samples, and strict instructions to brush and floss religiously, and chew carefully. We may look into some sort of mouthguard as well, in the meantime. And I think I'll start doing some reading up in the dental literature too. At least the toothpaste doesn't make me gag, so far.

Aches and Pains

I might as well catalog what remains with me since going off Nexavar. I stopped using it in February when it became apparent that the tumor in my right lung was growing; I figured it would take some months to see what side effects would stick with me.

I still have some edema in my legs and feet, particularly my left foot. Perhaps this is related to the relative severity of hand/foot that I had in my left foot, whenever those episodes cropped up? At any rate, if I'm on my feet for long periods of time and especially if the weather is hot, or if I'm sitting still for long periods, my left foot invariably swells. The skin on my left shin is always slightly tender, and I've had swelling as far up as my knee on really bad days. Last week Dr. SC at OSU told me that most of his renal cell patients have swelling in the lower limbs, so I guess I should not be surprised. Whether it's a condition of the disease or of the drugs, I can't say. Since February the severity has gradually decreased, so what's left I can certainly live with.

I still have joint pain. Again, this seems to be a common and relatively permanent result of taking antiangiogenic drugs. It's controlled with Dilaudid, and I can live with it.

I still have fatigue. I generally get up with Saint H to see him off, and now I stay up for a couple of hours beyond his leaving so that I can give Duke his morning insulin shot. Then I'm ready to stretch out for a couple of hours; often I end up taking a nap in the afternoon, aided and abetted by Duke. I have been fatigued since long before my diagnosis, but it's gradually gotten better over the last four years. Generally, so long as I don't overextend, I can keep up with everything needed to run the house. I can live with that.

Today is lightly overcast, and tomorrow promises to return to real July heat and humidity. The fledgling barn swallows are perched in the shade on the back of the house, squalling to be fed and the adults are wheeling through the air obliging them. I can definitely live with that, too!

Time Marches On

Yes, I've gotten out of the habit of posting; in part because I'm uncertain how much I can say about the trial. And, I'm afraid, as a creature of habit, going without my laptop for all that time this spring broke my daily routine - I don't check my email daily; I don't read the online newspapers; I don't post to my blogs; I don't read my friends' blogs consistently. I'll try to be better about it ...

Monday's trip to Cleveland, the third treatment in the second cycle, brought an interesting observation. I can't predict how I will react to the Benadryl dose at all! I was deeply asleep moments after the stuff was administered, and stayed deeply asleep for the afternoon; it carried over as aching dopiness into Tuesday afternoon. I really dislike being subjected to that level of disorientation. But, having heard a description of reaction to the trial medication unmitigated by Benadryl, the discomfort is quite bearable by comparison. According to Nurse Vicki, the pre-meds were added to the protocol after several patients experienced wild fluctuations in blood pressure and heart rate, and respiratory distress of a frightening magnitude. She said, "It took two hours each to stabilize the two patients here who suffered from these reactions, and we don't ever want patient and family to have to go through that if we can help it."

I'd love to know more about how health professionals, the companies, the NIH and the FDA negotiate changes to the protocol as a clinical trial progresses. I'll be doing a little poking about; if I can find anything out I'll pass it along.

Shades of the past: We finally got barn swallows to nest in the tractor shed this year. Yesterday the first two of the brood fledged, following their parents to perch on the house gutters while the adults hunted. Last night at dusk Saint H and I were sitting on the front porch glider, watching them dive-bomb outside kitty Jezebel as she came from the barn to join us on the porch. When I was growing up, we always knew when indoor/outdoor cat Denny was coming back to the house by the dive-bombing barn swallows. I've been waiting for a long time to see this again!

Little Ol' Deviant Me

Well, I've been busy since the last posting. My computer is now fixed (fingers crossed that it stays that way). We've completed the first 3 treatments on the clinical trial and I've not had significant side effects to date. However, last week we ran head-on into one of the "things one signs on for" in agreeing to a clinical trial.

Every clinical trial should include a contract, of sorts, between the trial and the patient. I signed one which outlined the side effects, documented the intent of the trial, and specifically stated what responsibilities I have as a participant.

Wednesday afternoon, in the midst of terrible storms and changeable weather, I had a terrible migraine. Later in the evening I developed a fever of 101.2 degrees. I thought to consult the document I'd signed and, lo and behold, I was to call in and report to the Cleveland Clinic for further information, if I had a fever over 100.5 degrees. The oncology fellow on call directed me to go to an emergency room, so off we went to OSU ER, at about 11:30 p.m. After consulting with the Cleveland Clinic, the ER docs bundled me off to the James for admittance, where I landed about 3:30 a.m. At Cleveland Clinic's direction I was placed on an IV course of antibiotics and settled in for the results of blood cultures.

By the time I was in the James, my fever had gone, but we had to wait for 24 hours for the results to come back. I was finally released after observation and constant dosing on antibiotics on Friday afternoon. I now have 4 new antibiotics on my drug sensitivity list, woo-hoo!! Basically they could find nothing wrong with me (I'd suspected that all along, since I have a history of reacting badly to weather changes).

On Sunday I went off for a haircut and lunch with friends. Later that evening I got violently sick to my stomach; I offer no details but it was distressing and unpleasant. I had no temperature and was finally able to sleep once the vomiting was over. The patient contract said to call in if more than one episode of vomiting occurred during a day; I figured it was essentially one long episode and decided I wasn't reporting in.

On Monday morning I called in to Nurse Vicki, told her that I'd had vomiting the day before and was feeling okay but didn't really want to make the trip up that day; would that invalidate my trial participation? She said, "I'll just note this as a deviation, that you didn't come in for your appointment, and I'll see you on Friday for the screening tests."

So now, I'm a deviation from the standard protocol. I'm glad that I didn't get bounced off the trial for missing my last appointment of the cycle, and I'm glad I don't have to make the weekly trek anymore. Let's just hope that the screening tests go well on Friday so I can start treatments again next week.

Bam!

We went off to Cleveland for the second treatment yesterday. We spent less time at Club Vampire - no need to search for veins, thank you very much. The trial protocol requires only an hour's monitoring for the second and third treatments in each cycle, so the waiting time was cut by three hours.

I'd always maintained that Benadryl doesn't affect me, when warned of its drowsy factor. I now have to amend that. Benadryl in pill form hasn't affected me in the past, and may not do so in the future. However, Benadryl as an infusion is another matter altogether.

Picture yourself sitting quietly in a chair, talking with your beloved and your friendly nurse. You've got a pile of knitting on your lap and lots of free time in your near future; it's a wonderful prospect provided that you don't get sick or have a reaction to the treatment. Then someone steps up with needle in hand, says, "Here's your pre-medication dose of Benadryl," and it's injected into the line leading to your port and thence directly into your bloodstream.

Suddenly you feel not quite sick, not quite awake and not quite coherent. Your knitting is in hands that don't belong to your body; your loved one is floating away, and your nurse is asking you questions that your brain can't process. For my part, I feel like the inside of my mouth has suddenly been sprayed with glue. I've called into a local radio talk show a couple of times, and find the slight delay between speaking and broadcast to be very disconcerting. Being on Benadryl is a lot like that!

I have to say I've fallen asleep very quickly both times, and suspect that this will become the new normal routine. Likewise, it seems to take a long time for the effects to wear off, but sometime around mid-afternoon I've managed to start feeling normal again, both times. I hope that will also continue to be the norm.

Since we got out early, we managed to squeeze in a visit to Cleveland's fabulous West Side Market. Eleven dollars bought us almost more produce than we could stagger away with; and we didn't even make it all the way around the market. I see more trips there in the future!

My laptop is being evaluated for repair. I hope to have it back soon; friend M has given me carte blanche to use her desktop machine whenever I need to. So email is backing up and I'm not looking forward to plowing through it all when the time comes ...

Long-Term Effects?

I had an appointment with Dr SC at OSU on March 31. His nurse K (sweet, blonde, tiny mother of twins) and I were going over the routine questions - how did I feel, what level of fatigue, what meds taken and when - when she mentioned, "I don't know but that you may be one of the longest-term patients ever on Nexavar. Certainly you're our longest-term patient; all our other folks have been off the drug within a year of starting it."

I started thinking then about the side effects that I've gone through, and how I feel now. What's due to Nexavar? What's due to RCC? What's due to advancing years and admittedly lethargic habits?

Unfortunately we think that the joint pain is probably permanent. It's eased somewhat since I went off Nexavar in February, but hands, hips, knees and lower back are still troubling me.

Fatigue is probably permanent too. This past week I started some classes in an adult education program; even cutting back on the number of classes I'd like to take and keeping it to two days a week only, I still found myself longing for the end of the week so I could return to my usual routine for a few days.

I want to review my current medications with Dr. G - is my high blood pressure permanent too? That came with Sutent and Nexavar, and it would be great if I could forego the 3 medications I take for that. Likewise, my hypothyroidism. Could I possibly return, even temporarily, to a state of taking nothing except pain relievers? I suspect that's a dream that won't come true, but it's entertaining to think about it.

Vocabulary Lesson

If nothing else, I know that to be physically challenged by an uncommon disease is also to be mentally challenged to learn more. I've learned about RCC; I've learned about the structure of medicine in this country; I've learned about clinical trials and drug discoveries; I've learned about my own limits and how to make compromises between "want to do" and "able to do". Along the way I've discovered a whole new vocabulary. Sometimes I pursue new words out of curiosity. Increasingly, though, I find that I am doing research out of necessity.

This week I learned a new word: ascites. In clinical terms, it's a buildup of fluid in the peritoneal cavity caused by the liver's inability to process wastes. In more approachable terms, courtesy of Dr SC's lead nurse Kelly, "Think of the liver as a garbage disposal. Ascites is what backs up when the system's clogged."

I learned this one because it appears that I've developed it. We won't know for certain until I've undergone my usual round of scans this coming Wednesday, but I've got the classic symptoms: distended abdomen, feeling of fullness, loss of appetite, constant low backache, general fatigue. What makes this fatigue different from my normal level, you may ask? It's hard to explain, but I feel heavy, lethargic, and always uncomfortable. It could be worse; Kelly described the backache as "pregnant back" - I figure she should know, as she has twins. The backache is accompanied by gross distension of the belly, sometimes approaching "full-term" size. I've never been pregnant myself, so I can only distantly appreciate what every mother goes through.

I'm on a diuretic and have doubled my dose of Dilaudid. So far, after only two doses of the diuretic, my abdomen has deflated, my appetite has returned, and my backache has receded. Last night I slept the night through and I feel more energetic today than I have for a week.

When I encounter a new word these days, I think of "The Secret Word" on Pee-Wee's Playhouse. "Scream real loud!!" What a way to learn!

Hankies at the Ready

To judge from TV commercials, we need to lose weight - buy a workout machine - consolidate our credit debt. We burst into song over low-priced car insurance. We bond with our families over pizza or fried chicken, often in the new family vehicle. New cleaning supplies and the right deodorant are the keys to a happy home. Our women search obsessively for new wrinkles or unwanted facial hair. Our men worry about sexual performance and fret over falling hair. Everybody has dandruff and yellowed, stained teeth. All we need to do, it seems, is buy the right product and our problems are solved. But then, once the products are bought, there's a new twist:

We're a nation of victims, trembling in the corner. We've been pushed into that corner by Big Pharma, or Incompetent Medical Practitioners, who have robbed us of our rights, our dignity, our fortunes (aided and abetted by Heartless Insurance Companies). We would surely be crushed in that dark corner, were it not for the selfless Personal Injury Lawyer, looking straight into the camera and solemnly promising to Come to the Aid of Injured Citizens.

Last summer a new appeal was launched on the airwaves: "If you or someone you love has suffered from Jaw Death ..." (cue dramatic music). Hmmm, our old friend osteonecrosis of the jaw. A class action suit was filed April 10, 2006, against Merck, maker of Fosamax. Hmmm, Merck, maker of Vioxx. Yummmm, deep pockets and a record of settling lawsuits. Parallel class action suits have been built and subsumed into the Fosamax suit for other bisphosphonate drugs Actonel, Aredia, Boniva, Skelid and Zometa. Didronel and Reclast are mentioned as bisphosphonates but I've not seen specific suits for these products.

This site summarizes most of the available information on the disease and its causes, treatment options, and other resources. On the whole, it's well presented, especially as one emanating from a personal injury lawyer's office: no scare tactics, little overstatement, very straightforward (but don't overlook the handy form for more information)

But wait! Is this as risky as it sounds, when Mr. Soulful Personal Injury Lawyer is crying Real Tears over your plight? The University of Alabama-Birmingham has put together an excellent site on osteoporosis, which includes this reasoned risk assessment. Kind of like putting sour cream on chili, to my thinking.

I'm not saying that any drug is completely safe, that any pharmaceutical company is blameless, that there isn't smoke without fire. I find it interesting that, after the initial flurry of ads, I've never seen another one. Did they not get enough response to continue? One can only hope ...

Yum, Yum - Part 2

During the time that I was struggling with food on the Sutent trial, I kept a barebones food diary. I recorded everything that I ate, in what quantity, at what time, and whether or not I had any reaction. By reviewing the food diary, I learned that I was better off to eat small "meals" during the day, and I could easily identify foods that triggered nausea and vomiting. "Meals" could be a pretty broad term, and depended in part on what foods I reacted to. I set up a pattern that made sense to me and have stuck to it pretty well since - small helpings at "normal" mealtimes plus a couple of snacks during the day. I'm not always good about sticking to healthy snacks but for the most part I'm pretty conscious of what I'm putting in my mouth (except for anything from Andrew's!)

I have one kink in my requirements: two medications must be taken on an empty stomach (Nexavar and Levothyroxine). "Empty stomach" means no food for two hours before, and one hour after, taking the medication. I've gotten around that by scheduling those medications in mid-afternoon, between 2:00 and 4:00 p.m. Those taking Nexavar on the normal schedule (that is, 4 times more than I'm taking) have the additional burden of scheduling that medication twice. My buddy Bruce sets an alarm for 4:00 a.m., takes his Nexavar, and goes back to bed.

Lest you think that the "empty stomach" requirement isn't a big deal, ignoring it can alter how the drug is taken up by the body. If Nexavar is taken with food, for example, its effectiveness is reduced by 60-75%. Why go through all those side effects for nothing? Yet the "empty stomach" recommendation, the standard for clinical trials and oncologists' advice, may not be universal. A recent study suggests that, in some cases, drug efficacy may in fact be improved by taking it with food.

It's become a controversial subject in oncological circles, and more research will be required. Ohio State University is seeking grants to study the relationship between nutrition and cancer therapies; I suspect others will be delving into this too. The more they find out, the better off we are.

Yum, Yum - Part 1

I have lived with one constant since diagnosis in 2000 - much of the time my appetite is suppressed. Often I will happily cook all afternoon and wait with anticipation for dinner, only to find that I'm not very hungry when it comes time to eat. It's not that I can't taste things, or that what I'm eating doesn't taste good, I just can't eat very much.

Over the past 3 years I've had two especially trying periods: first, in early 2005, when I tried the high-dose interleukin 2 therapy, and second, in late 2005, when I was on Sutent. High-dose IL2 is a very aggressive, unpleasant therapy that requires hospitalization and constant monitoring. One of the first things to go is the appetite; often, people are too nauseated to eat anything. I was lucky - I could eat and keep food down, but nothing tasted good. So I didn't eat much for two months while we tried that treatment.

While on Sutent I experienced lots of side effects besides internal bleeding. Nausea and diarrhea were chief among those side effects. I was hungry, and I could eat, but very little stayed down for long - generally within 10 minutes I was in the bathroom vomiting. I worked with a nutritionist at Cleveland Clinic to try to figure out how to combat this. I tried smoothies, the "BRAT" diet (bananas, rice, applesauce and toast), and eating 5 small meals daily. Nothing worked; of course I had to go off the drug eventually anyway, but I went through another 3 months of not being able to eat.

One rather amusing thing that happened while on IL2: I wasn't able to sleep much and couldn't concentrate, so watched a lot of TV to pass the time. One night I was watching the Food Network (tailgating/BBQ contests) and a nurse asked what was on. She laughed when I told her and commented, "Everyone on this floor is on IL2 or some form of chemo. Almost nobody can eat. Ninety percent of the time, when the TV is on, they're watching the Food Network."

One can dream, can't one?