Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer
Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
Summary
Investigators plan to carry out a study to investigate two different pills, Vitamin D and
melatonin, and whether they can reduce the spread of cancer cells in the tumors of women with
breast cancer. These pills are inexpensive and have very few side effects. A large number of
studies using cell cultures and animals have shown that both vitamin D and melatonin can help
destroy breast cancer cells. However thoughtful and well-designed studies are necessary on
humans to see if they can decrease the spread of breast cancer, and possibly even prevent
breast cancer. The proposed study aims to understand the anti-cancer activity of vitamin D
and melatonin. This knowledge will assist in creating efficient cancer prevention strategies
for Canadians. This study will include women with breast cancer who are being planned for
surgery, and will assess whether treatment with vitamin D (dose of 2000 IU per day) in a
group of 36 women, or melatonin (dose of 20mg per day) in another group of 36 women, or both
pills together in yet another group of 36 women, reduces the spread of cancer cells when
compared to a fourth group of 36 women who are treated with sugar pills. To do this we will
measure a substance in the blood called Ki67, which provides information about the spread of
cancer. Investigators will compare the Ki67 levels in the 4 groups, and all women will
receive identical appearing pills so they will not know which treatment they received.