NCT01965522

Anti-proliferative Effects of Vitamin D and Melatonin in Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Juravinski Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Stage Breast Cancer

Interventions

Type	Name	Description
DRUG	Melatonin	Melatonin 20mg taken orally once daily. This is in the form of one capsule which contains two pills of melatonin, 10 mg each.
DRUG	Vitamin D	Vitamin D 2000 IU taken orally once daily. This is in the form of one capsule which contains two pills of vitamin D, 1000 IU each.
DRUG	Placebo (melatonin)	Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains melatonin tablets.
DRUG	Placebo (vitamin D)	Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains vitamin D tablets.

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-08-01
• Completion: 2017-05-01
• First posted: 2013-10-18
• Last updated: 2017-06-16

Locations

2 sites across 1 country: Canada