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

Head and Neck Cancer Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02980653
Study type Interventional
Source TTY Biopharm
Contact Hung-Ming Wang, M.D.
Phone +886 3 3281200
Email whm526@gmail.com
Status Recruiting
Phase Phase 2
Start date May 2015
Completion date December 2017
View Details
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