Trial Outcomes & Findings for Melatonin Postoperative Sleep Study in Breast Cancer Patients (NCT NCT00506064)

Results Overview

Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

4 participants

Primary outcome timeframe

Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative

Results posted on

2012-12-05

Participant Flow

Recruitment Period: 01/26/07 through 10/10/07. All participants recruited at UT MD Anderson Cancer Center.

Protocol terminated early as unable to accrue cases. There were four patients accrued of which three were not assigned, therefore data available for only one case.

Participant milestones

Participant milestones
Measure	Melatonin 0.15 mg/kg capsules by mouth daily	Placebo Starch capsules by mouth daily
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Melatonin Postoperative Sleep Study in Breast Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Melatonin n=1 Participants 0.15 mg/kg capsules by mouth daily	Placebo Starch capsules by mouth daily	Total n=1 Participants Total of all reporting groups
Age Categorical <=18 years	0 years n=5 Participants	—	0 years n=5 Participants
Age Categorical Between 18 and 65 years	1 years n=5 Participants	—	1 years n=5 Participants
Age Categorical >=65 years	0 years n=5 Participants	—	0 years n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	0 participants n=5 Participants	—	0 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative

Population: Since unable to accrue an adequate number of cases with data, unable to provide analysis.

Objective responses measured by wrist actigraph (measures sleep movement), and the Sp02 monitor (measures the % oxy-hemoglobin in the blood)

Outcome measures

Outcome data not reported

Adverse Events

Melatonin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Una Srejic, MD / Professor

UT MD Anderson Cancer Center

Phone: 713-792-6914

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place