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
- 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
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
- 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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Kathryn M. Greven, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|