NCT02980653

Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With H&N Cancer Who Receiving CCRT

A Phase II Study Assessing the Efficacy of Prophylaxis Use of Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With Head and Neck Cancer Who Receiving Concurrent Chemoradiotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: TTY Biopharm · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate the population prevalence of critical body weight loss ( more than 5% from baseline) in patients with Head and Neck cancer. Secondary Objectives: To evaluate the impact of appetite, and performance status; To evaluate the change of quality of life (QoL); To evaluate the incidence of infection and hospitalization; To evaluate the safety profiles

Detailed description

Hypothesis testing will be used to determine the patient number in this study. According to a preliminary data at CGMH-LK, the investigators have the untreated patients with population prevalence of critical weight loss that is 0.56, and the investigators assume the study treated population prevalence is 0.4, power set in 0.9, alpha set in 0.05.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Megestrol acetate (MA) 400 mg/day	Megestrol acetate (MA) will be given on 400 mg/day as eligible patient begin CCRT. Total treatment period is for a maximum of 12 weeks calculated from the date of first dose.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-08-01
• Completion: 2017-12-01
• First posted: 2016-12-02
• Last updated: 2017-01-18

Locations

1 site across 1 country: Taiwan