Trial Behind, Trial Ahead

I'm collecting the high fives now, if you please. My last round of chemo and my final injection of Neulasta are behind me. I face three weeks of recovery from this latest round of drugs, and then I can officially close this chapter of treatment. What a relief!

My medical team seems to think that I weathered chemo well. During my check-up, the nurse noted approvingly that I both fended off nausea and retained my eyelashes. While I'm pleased to have been a gold star patient, I'm ready to part ways with the intravenous drugs. Indeed, the only injection system that I want any proximity to at the moment is the one that regulates the flow of fuel in my car. Unless....

And this a big unless. I'm currently weighing whether to participate in a clinical trial sponsored by the National Cancer Institute, which includes the possibility of receiving several IV drug doses over the next three years. Since I'm not sure how to proceed, I hope that you'll bear with me while I publicly gnaw on my decision here.

The trial, which is being carried out at cancer centers across the country, looks at the effects of three different osteoporosis drugs on preventing bone metastases in women with breast cancer. Bones are the most common site for breast cancer cells to migrate. An earlier study, conducted in Europe, has already shown that one osteoporosis drug -- Clodronate -- had a positive impact on reducing metastatic bone cancers in patients with early-stage breast cancers. Presumably this outcome was because stronger bones are more impenetrable to cancer cells than weaker ones. Now, U.S. researchers want to compare Clodronate to two other drugs -- Ibandronate and Zoledronate. Six thousand women are being recruited for this three-year study, including me.

All of this sounds fine. However, no drugs are free of potential side effects. Osteoporosis drugs fall under the pharmaceutical group called bisphosphonates. Basic Internet research turns up articles from all corners of the globe citing correlations between bisphosphonates and incidents of serious problems in the jaw bone. Although these complications are rare, bisphosphonates may trigger "osteonecrosis" of the jaw, which means that the cells in the jaw bone die off causing permanent damage and significant dental problems. This side effect occurs more often in one of the study's three drugs, Zoledronate, which is given intravenously. The two other drugs are given orally.

This clinical trial is double-blind one, meaning that neither the participants nor their doctors know to which prong of the study they will be assigned. Thus, every one has a one-third chance of landing in the Zoledronate arm of the study and thus assuming the greater risk of the potential jaw problems. Since USC/Norris is a research center and one of the study sites, I've been approached several times about my willingness to participate, and I've yet to give a definitive answer. I have until the end of May to either opt in, or skip the whole thing.

Usually a decisive person, I'm stymied by this choice. On the one hand, I tend to believe I would benefit from the Clodronate in a couple of ways. Since I have no reason to distrust the results of the European study, I would receive its assistance in warding off future breast cancer problems. Also, given my fair skin and small bone structure, I am definitely an osteoporosis candidate, so the Clodronate would also pitch in on that front. Finally, a voice in my head keeps whispering to me about the inherent rightness of stepping up when one is called upon to make a contribution to the greater good.

On the other hand, who wants problems with their jaw bones? While I'm not afraid of needles, I don't really welcome periodic doses of a strong intravenous drug over the next three years.

So, what to do? When faced with a decision that lacks an easy answer, my habit is to look for a piece of evidence that will tip the scale one way or the other. To this end, my oncologist has scheduled a bone density test to see if I have any evidence of osteoporosis now. The bone density test is a pre-requisite to participating in the clinical trial anyway, so I'm proceeding with the preliminaries without yet committing.

Feel free to share your thoughts here. While this is my decision alone, I'd welcome your input, so post comments or send e-mails. Clinical trials conducted on actual people are one way we gain knowledge. But they're not without some risk.

I can anticipate a couple of questions you may already have, so let me sort those out now:

1. Why not just take the Clodronate and skip the clinical trial? I posed this question, and my doctor's answer was only if my bones currently showed evidence of osteoporosis. The FDA has only approved Clodronate to treat osteoporosis, so he can not ethically prescribe it to a patient without evidence of bone loss. The results of the European study showing Clodronate's positive impact on breast cancer have not been replicated in the U.S., and the FDA has not adopted them.

2. Can I pull out of the clinical trial if I land in the Zoledronate group? Technically, yes. The study does not require a legally binding contract. But that's not my style, and I'd rather not be disingenuous with the researchers at USC, where I'm a patient. Either I commit fully to the study, or I skip it. That said, if I developed some problem during the study, I would, of course, step out.

Any thoughts?