Trial · NCT01805089
Melatonin Versus Placebo in Breast Cancer
NCT01805089, Early phase 1, Completed, Dana-Farber Cancer Institute; results first posted 2015-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin Versus Placebo in Breast Cancer. Trials, record NCT01805089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01805089
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin Versus Placebo in Breast Cancer
- NCT number
- NCT01805089
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 95 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Breast Cancer
- Interventions
- Melatonin 3 mg
- First posted
- 2013-03-06
- Last updated
- 2015-03-23
- Results first posted
- 2015-02-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo | 4 months | Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below. |
| Primary | Compliance | 4 months | To evaluate compliance with a 4 month course of melatonin. Compliance was assessed via pill counts. |
| Secondary | Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months | baseline and 4 months | Mood was assessed by the Center for Epidemiologic studies Depression Scale. The scale measures depressive symptoms in 20 items. Each question has a 4 point answer (0-3) so the scale range is 0-60. A higher score indicates more depression. Sleep quality was assessed by the Pittsburgh Sleep Quality Index. There are 19 questions each with a 3 point answer. The questions are grouped into 7 subscales and each has a value from 0-3. The 7 subscales are then added together to yield a global score with a range of 0-21. Higher scores indicate worse sleep. Menopausal symptoms were assessed by NCCTG Hot Flash diary. Subjects track the number and severity of hot flashes daily for 1 week. Subjects grade the severity of the hot flashes on a scale of 1-4, with 1 being mild and 4 very severe. Frequency and the severity determine the score . The minimum score is 0 (no hot flashes) and there is no maximum score. A higher score indicates more severe hot flashes. There are no subscales or no units. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo | 4 months | pg/ml | MEAN | |
| PRIMARY | Compliance | 4 months | participants | NUMBER | |
| SECONDARY | Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months | baseline and 4 months | change in PSQI score | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo | Melatonin | 4.59 | Standard Deviation 3.42 | pg/ml | |
| Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo | Placebo | 3.39 | Standard Deviation 2.25 | pg/ml | |
| Compliance | Melatonin | 43 | participants | ||
| Compliance | Placebo | 43 | participants | ||
| Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months | Melatonin | Change in PSQI | -1.9 | Standard Deviation 2.4 | change in PSQI score |
| Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months | Placebo | Change in PSQI | -0.1 | Standard Deviation 2.0 | change in PSQI score |
| Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months | Melatonin | Change in CESD | -0.2 | Standard Deviation 4.6 | change in PSQI score |
| Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months | Placebo | Change in CESD | -0.0 | Standard Deviation 5.4 | change in PSQI score |
| Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months | Melatonin | Change in Hot Flash Score | -1.0 | Standard Deviation 6.1 | change in PSQI score |
| Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months | Placebo | Change in Hot Flash Score | -1.3 | Standard Deviation 3.9 | change in PSQI score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Melatonin 3mg | 48 | |
| Overall Study | STARTED | Placebo | 47 | |
| Overall Study | COMPLETED | Melatonin 3mg | 43 | |
| Overall Study | COMPLETED | Placebo | 43 | |
| Overall Study | NOT COMPLETED | Melatonin 3mg | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Melatonin | 3 | 48 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 47 | |
| other | Bad Dreams | General disorders | Melatonin | 4 | 48 | |
| other | Bad Dreams | General disorders | Placebo | 1 | 47 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melatonin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Melatonin | 7 | 48 |
| Total, other adverse events | Placebo | 1 | 47 |
| Total, serious adverse events | Melatonin | 0 | 48 |
| Total, serious adverse events | Placebo | 0 | 47 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Melatonin vs Placebo: Compliance | Trial comparisons |
| Melatonin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01805089
GET https://conductscience.org/api/trials/v1/NCT01805089/registered