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Melatonin Postoperative Sleep Study in Breast Cancer Patients

This study has been terminated.
(Terminated due to low accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00506064
First received: July 23, 2007
Last updated: December 3, 2012
Last verified: December 2012
Results First Received: March 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Melatonin
Drug: Placebo
Behavioral: Questionnaire

  Participant Flow
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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
  Description
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  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  1     0     1  
Age  
[units: years]
     
<=18 years     0         0  
Between 18 and 65 years     1         1  
>=65 years     0         0  
Gender  
[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
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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
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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
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00506064     History of Changes
Other Study ID Numbers: DM02-563
Study First Received: July 23, 2007
Results First Received: March 29, 2010
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board