NCT00006799

Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Anorexia
• Cachexia
• Head and Neck Cancer
• Quality of Life

Interventions

Type	Name	Description
DRUG	megestrol acetate
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2000-10-01
• Primary completion: 2002-09-06
• Completion: 2002-09-06
• First posted: 2003-07-28
• Last updated: 2021-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study