Our next human trial

Our goal is to combine the knowledge we gain from our laboratory research with a human study we're hoping can begin this summer. Our human trial is designed to test two diets in women with breast cancer between the time of positive biopsy and the tumor's surgical removal. 65 patients will be randomized to two dietary groups, with 45 patients eating a low carbohydrate ketogenic diet and 20 on a low fat diet supplemented by 5 servings per day of fruits and vegetables. While both diets have been proposed to be healthy no one really knows for sure. So we will compare the tumor at surgical removal to see if measured proliferation markers and tissue death markers will differ according to the patient's diet.

I've spent this past week writing up the proposal and consent form for submission to the Einstein Investigational Review Board (IRB). IRB approval is an essential step in all human trials. Its purpose is to insure that all research studies involving human beings are conducted ethically so that only fully informed subjects who agree to participate will do so. Our study is quite harmless, but IRB's and regulations are clearly necessary for all human experimentation. We should realize that invasive experimentation was still being performed on human subjects without their consent in the not too distant past.