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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
105
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.
Chang-Gung Memorial Hospital, Linkou
Linkou District, Taiwan
RECRUITINGCritical body weight loss
To evaluate the population prevalence of critical body weight loss ( \> 5% from baseline) in patients with Head and Neck cancer
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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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.
Time frame: 12 weeks