NCT01805089

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for early_phase_1 breast-cancer

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 23, 2015

Completed
Last Updated

March 23, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

March 4, 2013

Results QC Date

April 30, 2014

Last Update Submit

March 3, 2015

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo

    Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.

    4 months

  • Compliance

    To evaluate compliance with a 4 month course of melatonin. Compliance was assessed via pill counts.

    4 months

Secondary Outcomes (1)

  • Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months

    baseline and 4 months

Study Arms (2)

Melatonin 3 mg

ACTIVE COMPARATOR

Taken orally, once per day, at/around 9:00pm

Drug: Melatonin 3 mg

Placebo

PLACEBO COMPARATOR

Taken orally, once per day, at/around 9:00pm

Drug: Melatonin 3 mg

Interventions

Melatonin 3 mgDRUG

Melatonin vs. Placebo

Also known as: Melatonin
Melatonin 3 mgPlacebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of ductal carcinoma in situ, lobular carcinoma in situ or stages 1-3 breast cancer
  • Not currently receiving chemotherapy or hormonal therapy
  • Postmenopausal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr. Wendy Chen
Organization
DFCI
wychen@partners.org
617-632-3800

Study Officials

  • Wendy Chen, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 6, 2013

Study Start

October 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 23, 2015

Results First Posted

February 23, 2015

Record last verified: 2015-02

Locations

US(2)