I have been asked to participate in a Phase III Randomized Study at MD Anderson which is for the prevention of recurrence of primary tumors and development of secondary primary tumors for Stage III and IV head and neck patients. One half of the group will receive treatment and the other half will only be observed.

The treatment will consist of:
1.CRA, also known as accutane
2.Vitamin E
3.Interferon injections

I remember being told by one of my buddies with Hepatitis C that interferon can be pretty strong stuff. The study nurse told me that there are side effects like fatigue and flu like symptoms.

Here I am still not back to normal from my radiation and chemo that ended in early September, being asked to inject something that will cause more fatigue and uncomfortable symptoms. The nurse tries to sell the protocol by telling me that I will be closely observed, whether or not I am in the half that receives the drugs and that the first 3 years are the time of most common recurrence. She said that the Phase II study had " good activity " meaning that 89 to 90% had no recurrences during the observation period.

I am still not able to swallow solid foods or pills, which means that I would likely have to dissolve the vitamin E and CRA ( whatever that is),in order to swallow it, and as I said, receive the interferon in shots. I am trying to get back to work and , I hope, back to a normal life once I can eat and get off this PEG tube. I am not sure that I want to take something that makes me feel bad and sets back my progress, taking away my energy. Furthermore, I would likely be pissed if I am one of the ones that the computer chooses for observation only.

I would appreciate any input that any of you can provide me about this decision.Thank you.

Danny G.

A fine friend with a wonderful upbeat spririt had kidney cancer that went to his lungs. He was in a test group that got Interferon and Thalidomide injections. Unfortuantely it later spread to his brain and bones, before he died last November. He was treated with radiation for the brain cancer.

i wish better results to the Head/Neck study group.

larryb

That is definitely a tough one to call! Obviously it is a choice only you can decide upon. The only advice I could suggest is to carefully consider how your cancer is now - and what is the prognosis like for you as it stands today. Did anyone offer any other treatment options? The best thing to do is to talk it over with family/friends and of course - ask plenty of questions to your health care professionals. I know I would feel the same way as you do, if I were only in the "observation" group. I figure if I were to ever put my body through that kind of rigorous treatment, after already going through hell with previous treatments - it had better not be for "nothing" (aka: observation)! I wish you all the best in whatever your choice may be. Please keep us posted on your decision and how things are going.

That would be tough to call, I know when I started my treatment I was asked to be the first to trial a new protocol for the medication ethyol. It's main purpose is to protect your saliva glands against radiation. It had always been given by IV before but it made everyone extremely nauseated to the point they would quit taking it. They wanted to give it in an injection between the layers, just under the skin. There was a chance of some pretty nasty side effects but given all the options and discussing it with my family I opted to do it. I completed 40 treatments and was able to withstand the side effects, which proved to be minimal. To date this is how the medication is being administered to everyone. I had laryngeal cancer in it's first stage. I underwent 40 radiation treatments, post 6 months and the cancer is gone. For me I don't have any regrets but your situation sounds to be different. Wish you all the best and I would like to konw what happens. Mike

When I had been out of treatment at MDACC about a year, I was contacted to see if I would like to participate in the last round of clinical trials related to this very same program. I declined. But before you follow in my footsteps, let

Thank you Brian and others for your suggestions. Since my last posting I have done some research on the web relating to interferon and vitamin A(accutane) and vitamin E. The concept is interesting as the purpose of all three is not to kill anything, like chemo, but to fortify one's immune system to protect itself better against recurrences of the primary tumor or secondary primary tumors.
The study seems to be concerned with a 3 year period wherein most recurrences apparently manifest themselves. The Phase II study allegedly , as I think I said, had 89 to 90% of the 45 participants with no recurrent tumors.
Before absolutely rejecting the program I intend to have a discussion with a couple of doctors including the one who is in charge of the protocol. However, my inclination, like yours Brian, is to pass on the study. It seems that I am on the cusp of feeling so much better and regaining my energy...and I just hate the idea of taking drugs that would cause me to feel ill again, at a time when I am not in need. Plus, it seems a little early to me to get involved in such a program when I am just getting over my original treatments and have such a long way to go regarding swallowing and eating solid food.

Thank you everyone....I really appreciate the input that any of you have.

Danny G.

Hi Danny,

I wish you luck in your decision. My daughter is facing a similar decision. Not a matter of whether or not to participate in a clinical trial, but whether or not to undergo chemo. She had surgery for removal of her stage 3/4 base of tongue tumor and neck dissection in Sept. and completed RAD a week ago. Now she has to decide about the chemo.

I'm sure most of you are aware that this is a very controversial issue. Most of the studies have failed to show that adding chemo increases the survival rate. But it also hasn't been proven that it doesn't help. Bottom line - no one knows if it helps or not.

What they do know is that there is possible risk of kidney damage, nerve damage, hearing loss, more mouth sores and the chemo may actually precipitate a recurrence!?!

If she doesn't do the chemo and has a recurrence, she will always feel it is her fault for not doing all she could to fight it. But she could have complications from the chemo that would be almost as bad. I've heard the old saw "the cure is worse than the disease". Now I really know what it means! How does one determine when the potential risk outweighs the possibly minimal benefit?

I can't even begin to imagine being in Heather's shoes right now. I have been a huge advocate of researching everything possible during her battle with cancer and I have given her lots of advice based on that research. But none of my research has given me an answer to this dilemma. I am at a complete loss.
Thanks for listening.

Rosemary