I was wondering if anyone has had any experience with any sort of post treatment preventative therapy.

I'm off to M. D. Anderson bright and early tomarrow morning to start the process of joining a phase III study of post treatment adjuvant biologic therapy with the intent of preventing recurrence. The study consists of combining 13-cis-retinoic acid (13-cRA - Accutane), alpha-interferon (Rogeron) and vitamine E. They are going to run baseline blood work, chest xray and head and neck CT scan. Then they will randomize me either into the control group or the medication group. The study lasts one year.

I must admit to some misgivings about this. I have read the phase II study data for this drug combination and they have had pretty good results. The pase II data on the rate of recurrence and survival of the control group participants was pretty discouraging. My misgivings come from the possibility of being placed in the control group. And there are restictions that study participants are precluded from taking vitamine supplements of any kind. Additionally, some of the data they have provided says that high doses of 13-cRA alone is the only treatment that has been shown to prevent recurrence of head and neck cancer.

I am considering dropping out of the study if I am randomized into the control group and then I will request 13-cRA or perhaps the full study medication. After all science is a fine thing, but this is my life we're talking about.

I wanted to know if anyone has had any experience with these or similar drugs/therapies. I also would like to hear people's opinions specifically about the decision to participate in the study.

Thanks!

-Brett

I don't know exactly how to say this, because clinical trials are a complex subject. So let me say the simple part in this posting. The drugs that they are offering to test in this study would not be available to you anywhere else. If you like the results of the Phase two studies, you couldn

Brett..I know that this must be a terrible dilemma for you, but, you have a 50% chance of getting what could be ground breaking treatment. All I can say is, if we had this chance we would jump at it. My husbands cancer story is very similar to yours except he could not tolerate the amifostine and has a very dry mouth. Whatever your decision we will pray for you...
best wishes.
Marica

Thanks for the input, guys. After the baseline blood work and images were taken (which still show no sign of disease (I'm 10 weeks post treatment)), I was randomized into the control group. So I guess it's up to me to find my own "chemo prevention." I'm going to look into what I can do with diet and vitamine and herbal supplements. I'll post things I find interesting and relevant.

-Brett

Brett...send me a private email and tell me who your doctors are at MDACC that are doing the clinical trial. I'm curious to read/hear more...especially the part where the doctors get to know who is getting the trial drug and who isn't.

Brett, My husband was in this clinical trial, phase III. Like you, he was randomized to the control group. They followed his progress for a year. He is officially out of the clinical trial, but of course if anything comes up they want to know about it. We still see the same Dr we did when we were in the clinical trial, Dr Kies at MD Anderson. The thing about being in the clinical trial that I found really helpful is anytime we had a question, we could call our research nurse. She was great. Is he your DR? Brian, I am sure they would love to talk to you about this, as they are always looking for people to join this clinical trial.
Brett, my husband was Stage IV, TN2bMo, was upset about being in the control group also, but almost 4 years later is doing great.

Julie,

That's wonderful news about your husband! And very encouraging for me since I'm just now 4 months post-treatment and still dealing with the almost daily fear of recurrence or SPT. Dr. Kies is my primary medical oncologist while Dr. Garden is my radition oncologist and Dr. Diaz is my surgeon (although I didn't have surgery). You're right that any participation at all in the trial is good because of the almost instant access to the research nurse (Tess in my case). I'm also encouraged by the news Tess gave me that none of her controls have had a recurrence while there have been recurrences in the medication group. This kind of furthers my theory about getting cancer in the first place -- it's a roll of the dice. (but that's fodder for a completely different thread) In any case, thank you so much for your encouragement.

-Brett

Brett, My husband had the exact same Drs as you and Tess was our research nurse, so I guess my husband is one of the controls she was talking about. She is wonderful, we called her all the time. Anytime we were scared about a reoccurence I would call her. Now that some time has gone by, it is still in the back of our minds, but it does not occupy as much of our thinking. So, hang in there, everything seems to get better as time goes by. If you ever have any questions, please feel free to email us or post it here. I don't post very often, but I do read pretty regularly.
Julie