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Old 09-04-2008, 10:17 AM   #7
Jyber
Senior Member
 
Join Date: Oct 2007
Location: PA
Posts: 27
Just wanted to let all those interested know that I got a thoughtful response from the pricipal investigator of the clinical trial.
He sent me an e-mail of apology, and said he would look into the matter more and get back in touch.
He called today. He said he fully agreed with me that this had been very inappropriately handled on his end. He has addressed this with the person who had coordinated the enrollment of subjects.
Re participation in the study, he said the study was without a medical director originally and now has one. It was subsequently decided that a history of cancer within five years would disqualify a subject. The protocol will be revised to reflect this.
The reason for the cancer exclusion is that 1) there is the risk of recurrance which might mean such a subject could not complete the trial and 2) clinically, a significant weight loss could be a symptom of recurrance and how would they differentiate between weight loss as a result of the trial and weight loss due to a recurrance? He advised me to work with my doctors on monitoring my weight loss just to be aware of this concern.
Anyhow, he did offer me the opportunity to choose either wing of the program, and while I could not be part of the trial, he would assign a grad student to monitor me weekly through whichever wing of the trial I would choose. I thought that was a gracious offer and told him so, but I have decided to do Weight Watchers locally. I figure without being in the actual clinical trial I would not have any particular commitment to the program so might as well do something local.
In any event, I do think changes were made as a response to my experience.
Thanks for the interest and feedback! :-)
__________________
diagnosed 1/07;
ER+, PR+, HER-2 +;
4.2 cm. invasive ductal carcinoma;
mastectomy 2/07;
SNB negative :-) ;
chemo (AC, followed by Taxol); herceptin scheduled until 6/08 but stopped 11/07 due to LVEF drop)
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