Clinical trial · Interventional
Melatonin Versus Placebo in Breast Cancer
A Randomized Trial of Oral Melatonin Supplementation in Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melatonin 3 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Melatonin 3 mg
- description
- Taken orally, once per day, at/around 9:00pm
- interventionNames
- Drug: Melatonin 3 mg
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Taken orally, once per day, at/around 9:00pm
- interventionNames
- Drug: Melatonin 3 mg
Primary outcomes (2)
- measure
- Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo
- timeFrame
- 4 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available