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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TTY Biopharm
• Collaborator: Chang Gung Memorial Hospital
• Treatments: Megestrol; Megestrol Acetate

Criteria

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.