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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Megestrol acetate (MA) 400 mg/day


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Megestrol<br>Single arm | Drug: Megestrol acetate (MA) 400 mg/day<br>* 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.<br>* Other names: Megest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Critical body weight loss | To evaluate the population prevalence of critical body weight loss ( > 5% from baseline) in patients with Head and Neck cancer | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of appetite | The assessment of appetite will be performed before the entry of the study, and then repeated every visit until end of study. The assessment of appetite will be performed by the visual analogue scale(VAS) within the range of 0-100mm(please refer Appendix II). The Differences from baseline status will be assessed, and results will be presented in percentages of improved patients out of those treated at the time of evaluation. | 12 weeks | 
| Impact of performance status | The assessment of appetite will be performed before the entry of the study, and then repeated every visit until end of study. The measurement will base on ECOG performance status scale(please refer Appendix I). The Differences from baseline status will be assessed, and results will be presented in percentages of improved patients out of those treated at the time of evaluation. | 12 weeks | 
| Change of quality of life (QoL) | Quality of life (QOL) will be evaluated since patient registration to off study by means of the Functional Assessment of Cancer Therapy-Head and Neck (FACT-. H&N), Version 4 (Traditional Chinese) (please refer Appendix III). The questionnaire will be completed under the assistance of a trained study nurse. | 12 weeks | 
| Incidence of infection and hospitalization | If any patient in the study period (3 months) suffer infection or hospitalization, that should be recorded on Case Report Form for the descriptive statistics analysis. | 12 weeks | 
| Safety profiles (percentage of patients with at least one occurrence of preferred term will be included, according to the most severe NCI-CTCAE v4.03 grade) | Adverse event / toxicity assessment are based on NCI- Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03), please refer Appendix IV), and will be evaluated before the treatment, and then repeated each visit until off study. The incidence and percentage of patients with at least one occurrence of preferred term will be included, according to the most severe NCI-CTCAE v4.03 grade. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase II study, Critical body weight loss, Concurrent chemoradiotherapy, Megestrol acetate, Head and neck cancer