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

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

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.

Inclusion Criteria:

• Patient who is confirmed the diagnosis of head and neck cancer and will receive concurrent chemoradiotherapy (CCRT).
• Patient who is capable to understand and complete questionnaires
• Patient who is convenient to receive body weight measurement
• Life expectancy of at least 12 weeks
• Age over 20 years old at registration
• Voluntarily signed the written informed consent form

Exclusion Criteria:

• Special populations that needs unique risk/benefit considerations. (Ex. Pregnant or nursing women or mental disorder patients, et al.)
• Any significant co-morbid medical condition that out of medication control. (Ex. Heart/renal/hepatic failure or poorly controlled diabetes, et al.)
• Any evidence of mechanical obstruction of the alimentary track, malabsorption, or intractable vomiting.
• Any thromboembolism event, e.g. cerebral or peripheral vascular disease
• Judged ineligible by physicians for participation in the study due to any safety concern.