Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss caused by cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss and improving quality of life in patients who have head and neck cancer and are undergoing radiation therapy.
|Anorexia Cachexia Head and Neck Cancer Quality of Life||Drug: megestrol acetate Procedure: quality-of-life assessment||Phase 3|
|Study Design:||Allocation: Randomized
Masking: Participant, Investigator
Primary Purpose: Supportive Care
|Official Title:||A Phase III, Double-Blind, Randomized Study Of The Effect Of Megestrol Acetate On Weight And Health Related Quality Of Life In Head And Neck Cancer Patients Receiving Radiation Therapy|
|Actual Study Start Date:||October 2000|
|Study Completion Date:||September 6, 2002|
|Primary Completion Date:||September 6, 2002 (Final data collection date for primary outcome measure)|
- Determine the effect of megestrol on the weight of patients with head and neck cancer who are undergoing localized radiotherapy.
- Determine whether health-related quality of life improves in patients treated with megestrol.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of treatment (radiotherapy alone vs radiotherapy plus platinum-based chemotherapy vs radiotherapy plus non-platinum-based chemotherapy) and type of radiotherapy (primary vs postoperative). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral megestrol daily beginning within the first three days of radiotherapy and continuing during 5-7 weeks of radiotherapy and for 12 weeks after completion of radiotherapy.
- Arm II: Patients receive oral placebo daily according to the schedule for megestrol in arm I.
Quality of life is assessed at baseline, at completion of radiotherapy, and then at 4, 8, 12, and 16 weeks after completion of radiotherapy.
PROJECTED ACCRUAL: A total of 48-144 patients (24-72 per arm) will be accrued for this study within 14 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006799
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|Study Chair:||Kathryn M. Greven, MD||Wake Forest University Health Sciences|