Melatonin Versus Placebo in Breast Cancer

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to determine whether melatonin taken every night can affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen are normally produced in the body and may influence breast cancer risk. Melatonin is also naturally produced in the body. Laboratory studies have shown that melatonin may decrease cancer growth and influence estrogen and IGF levels. Melatonin's effects on sleep, hot flashes, and mood will also be measured.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• History of ductal carcinoma in situ, lobular carcinoma in situ or stages 1-3 breast cancer

• Not currently receiving chemotherapy or hormonal therapy

• Postmenopausal

Exclusion Criteria:

• Stage IV breast cancer or systemic recurrences

• Prior malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

• Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, lutenizing hormone releasing hormone agonists currently or within the past 60 days

• Concomitant use of beta-blockers

• Concomitant nightly use of sleep aids at bedtime

• Working more than one overnight shift per month on a regular basis

• Concomitant use of postmenopausal hormone replacement therapy

• Concomitant use of black cohosh, flaxseed or soy in pill or supplement form

• Use of any type of oral melatonin supplementation within the past 30 days

• Use of warfarin (coumadin) within the past 30 days

• Active seizure disorder requiring the use of daily anti-epileptic medication