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Life Extension Magazine

LE Magazine January 2004
Melatonin and Cancer Treatment
By Eileen M. Lynch, PhD Oncology Research Scientist

Reprint of a letter from Cancer Treatment Centers of America

November 6, 2003

Mr. William Faloon
Life Extension Foundation
3600 West Commercial Blvd.
Fort Lauderdale, FL 33309

Re: Status of Protocol CTCA 01-07: A Multi-Center Randomized, Double-Blind, Trial Evaluating the Chronotherapeutic Role of Melatonin in the Treatment of Stage IIIB and IV Non-Small Cell Lung Carcinoma

Dear Mr. Faloon:

On behalf of Cancer Treatment Centers of Americaâ, I’d like to take this opportunity to say “thank you” for your donation of the thousands of capsules of melatonin for our clinical trial investigating the effects of melatonin, given at the appropriate circadian phase, in patients with non-small cell lung cancer. Indeed, the support of the Life Extension Foundation has made this landmark study possible. I’d also like to take a moment to update you on the progress of our study.

Our participating centers have enrolled thirty-one (31) patients onto the trial since December 2002, and we are looking forward to a steady increase in the number of patients enrolled in the foreseeable future.

To implement this program, your donation of high quality 20 mg doses of melatonin saved us considerable expense and effort. As you know, both federal and local IRB regulations require that we obtain an independent assay of any chemical agent that will be used in a human clinical trial. To fulfill these requirements, randomly selected capsules of melatonin and placebos were sent for analysis (HPLC and gas chromatography) to the Roswell Park Cancer Institute (an National Cancer Institute-Designated Comprehensive Cancer Center). As expected, the Life Extension Foundation’s products achieved all specifications on purity and dose.

Your product donations are now helping us discover more about the role of melatonin in cancer treatment. Indeed, this will be the first prospective randomized cancer clinical trial in the United States to investigate: (1) whether lung cancer patients produce a nocturnal pulse of melatonin prior to therapy; (2) what fraction of patients with advanced lung cancer suffer abnormalities in their circadian activity/rest rhythm, and 3) whether or not melatonin therapy, delivered at the appropriate circadian phase, improves the quality of life and overall survival of NSC lung cancer patients.

Thank you once again for Life Extension Foundation’s continued and generous support. We look forward to keeping you updated on the progress of this landmark investigation.

Best Wishes,

Christopher G. Lis, MPH
Vice President
Research and Development


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