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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Critical body weight loss
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Megestrol
Single arm
干预措施: Megestrol acetate (MA) 400 mg/day (Drug)
结局指标
主要结局
Critical body weight loss
时间窗: 12 weeks
To evaluate the population prevalence of critical body weight loss ( \> 5% from baseline) in patients with Head and Neck cancer
次要结局
- Impact of appetite(12 weeks)
- Impact of performance status(12 weeks)
- Change of quality of life (QoL)(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)(12 weeks)
- Incidence of infection and hospitalization(12 weeks)