At a glance
ClinicalIndex Comparison RecordEarly Ph 1Completed· 95 enrolled
Drug / intervention
Melatonin 3 mgdrug
Likely dose
Melatonin 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Oral Melatonin Supplementation in Breast Cancer Survivors
In Brief
A Early Phase 1 clinical trial evaluating Melatonin 3 mg for Breast Cancer. Completed, enrolled 95 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--
Timeline
Early Ph 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
Primary CompletionJul 2009
First PostedMar 2013
TodayJul 2026
First PostedMar 6, 2013
Enrollment StartOct 1, 2006
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.3 years ago
Interventions
Melatonin 3 mgdrug
Melatonin vs. Placebo