Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00513357|
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : September 14, 2012
Last Update Posted : December 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancer Lung Cancer||Drug: Melatonin Drug: Placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial of Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
20 mg by mouth daily for 4 Weeks
Placebo Comparator: Placebo
20 mg of Placebo before going to sleep at night for a period of 4 weeks.
Capsule by mouth daily for 4 Weeks
- Change in Appetite as Measured by ESAS [ Time Frame: Baseline and at 4 weeks ]Difference in ESAS (Edmonton Symptom Assessment Scale) assessment scores of appetite (symptom) from baseline evaluation [± 3 days] to 4 week evaluation [± 3 days], where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513357
|United States, Pennsylvania|
|Joan Karnell Cancer Center|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rony Dev, DO||M.D. Anderson Cancer Center|