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Melatonin Postoperative Sleep Study in Breast Cancer Patients

NCT00506064 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2012-12-05

Study results available
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Summary

Primary Objective:

To evaluate the impact of postoperative exogenous nocturnal melatonin supplementation on the early regulation of the sleep-wake cycle and its clinical impact (subjective improvement of the quality of sleep and reduction of cardiopulmonary events) during the first postoperative week following anesthesia and surgery in older breast cancer patients receiving a unilateral segmental mastectomy with or without intraoperative lymph node mapping, sentinel node biopsy and axillary node dissection.

Secondary Objective:

To collect data and validate the Postoperative Srejic Sleep SAT Survey Questionnaire (SAT implies relative subjective satisfaction of the patient's sleep in a scaled score out of 100 with 100 being the highest degree of satisfaction).

Conditions

Interventions

DRUG

Melatonin

0.15 mg/kg by mouth (PO) Daily

DRUG

Placebo

Two, three, or four starch tablet or capsules before bed

BEHAVIORAL

Questionnaire

Sleep study surveys, two per day completed each evening, lasting 10 minutes

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Una Srejic, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00506064 on ClinicalTrials.gov