Status:
COMPLETED
Melatonin Versus Placebo in Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
Brief 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 pro...
Detailed Description
If you agree to participate in this study you will be asked to undergo a blood test to find out if you are eligible. Approximately 2 tablespoons of blood will be drawn. The blood test will check your ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01805089
Start Date
October 1 2006
End Date
July 1 2009
Last Update
March 23 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215