Vitamin D and Melatonin: A Clinical Trial

Researchers: Dr. P. Rana & Dr. P. Muti
Co-Investigators: Dr. N. Hodgson, Dr. P. Lovrics, Dr. B. Heller
Project Status: Completed
Antineoplastic activity of Vitamin D and melatonin: A clinical trial

Much has been written about the potential to prevent cancer. Apart from stopping cigarette smoking and avoiding excess sun exposure, there is limited evidence to support other forms of cancer prevention. There have been some studies that suggest the potential for Vitamin D and melatonin to prevent breast cancer, However, the results are inconclusive. A novel clinical trial was designed where women who had undergone a biopsy for breast cancer where randomized to Vitamin D, melatonin, or placebo for a 4-week period while they were waiting for their definitive breast cancer surgery. Recruitment to this study occurred from December 2013 to April 2016 (approximately 2.5 years) and a total of 101 patients were recruited. The primary outcome was the absolute change in Ki-67 from the tumor sample in the initial biopsy and the tumor removed at definitive surgery. Ki67 measures proliferation of cells. The results showed that there was no difference between placebo and melatonin; placebo and vitamin D; and placebo and both agents. Hence, it was concluded that neither chemo-prevention drug had an impact on suppressing cancer cell growth. As a result, we did not pursue this line of research further.

It is noteworthy that over 100 women with a recent diagnosis of breast cancer who must have been very anxious and feeling very vulnerable, agreed to participate in a research study which would have very little bearing on their own condition. This is a remarkable!

Presentation: The design of the trial was presented at the 2013 Department of Oncology Student Research Day and at the 2014 ASCO annual meeting.