Early Phase 1
N=95
Melatonin Versus Placebo in Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01805089 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo — 4.59; 3.39 pg/ml — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Melatonin 3 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo |
4.59; 3.39 | <0.05 sig |
| PRIMARY Compliance |
43; 43 | — |
| SECONDARY Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months |
-1.9; -0.1; -0.2; -0.0; -1.0; -1.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01805089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.