Melatonin Postoperative Sleep Study in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00506064
Recruitment Status : Terminated (Terminated due to low accrual.)
First Posted : July 25, 2007
Results First Posted : January 25, 2011
Last Update Posted : December 5, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Melatonin
Drug: Placebo
Behavioral: Questionnaire

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 01/26/07 through 10/10/07. All participants recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
Melatonin 0.15 mg/kg capsules by mouth daily
Placebo Starch capsules by mouth daily

Participant Flow:   Overall Study
    Melatonin   Placebo
STARTED   1   0 
COMPLETED   1   0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Melatonin 0.15 mg/kg capsules by mouth daily
Placebo Starch capsules by mouth daily
Total Total of all reporting groups

Baseline Measures
   Melatonin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   0   1 
[Units: Years]
<=18 years   0      0 
Between 18 and 65 years   1      1 
>=65 years   0      0 
[Units: Participants]
Female   1      1 
Male   0      0 
Region of Enrollment 
[Units: Participants]
United States   1      1 

  Outcome Measures

1.  Primary:   Objective Sleep Response of Patients   [ Time Frame: Longitudinal study with major responses measured on days 0 (day of operation) and days 1-6 post-operative ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated early due to low recruitment, no analysis done.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Una Srejic, MD / Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-6914

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00506064     History of Changes
Other Study ID Numbers: DM02-563
First Submitted: July 23, 2007
First Posted: July 25, 2007
Results First Submitted: March 29, 2010
Results First Posted: January 25, 2011
Last Update Posted: December 5, 2012