NCT00637728终止3 期
A Randomized, Double-blind, Placebo-controlled Study of Megestrol Acetate Concentrated Suspension for the Treatment of Cancer-associated Anorexia in Subjects With Lung or Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
研究概览
简要总结
Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage II, III,or IV lung or pancreatic cancer
- •Fair, poor, or very poor appetite
- •Cancer associated anorexia/cachexia
- •Weight loss perceived to be associated with diminished appetite
- •Eastern Cooperative Oncology Group Performance score of 0, 1, 2
- •Life expectancy >3 months
- •Alert and mentally competent
- •Women of child-bearing potential required to use an adequate and reliable method of contraception. Post-menopausal women have to have been so for at least 1 year
- •Screening laboratory values must not be clinically significant (some exceptions per protocol)
排除标准
- •Brain, or head and neck metastases that may interfere with food consumption
- •AIDS-related wasting
- •Radiation therapy to the head and neck, abdomen, or pelvis within past 6 weeks, or anticipated during course of the study such that the result may interfere with food consumption
- •Conditions that interfere with oral intake, or ability to swallow
- •Absence of a normally functioning gut
- •Mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome
- •Intractable or frequent vomiting that regularly interfere with eating
- •Clinically significant diarrhea
- •History of recurrent thromboembolic events, a thromboembolic event in past 3 months, or long-term anticoagulation treatment for thromboembolism
- •Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism
- •Poorly controlled hypertension, or congestive heart failure
- •Pregnant/lactating females
- •Use within past 30 days of an appetite stimulant
- •Use within past week, or planned use during the study of parenteral nutrition or tube feedings
- •Chronic use of steroids within past 3 months (intermittent short-term use allowed)
- •Current use of or not willing to abstain from using illicit substances
- •Allergy, hypersensitivity, or contraindication to megestrol acetate
研究组 & 干预措施
1
Active Comparator
Megestrol acetate concentrated suspension 110 mg/mL
干预措施: Megestrol acetate concentrated suspension 110 mg/mL (Drug)
2
Placebo Comparator
Placebo suspension
干预措施: Placebo (Drug)
结局指标
主要结局
Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase
时间窗: 8 weeks
The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.
次要结局
- Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline(Baseline, Week 4 and Week 8)
- Change in Weight Over the Course of the 8-week Double-blind Phase(Baseline, Week 1, 2, 3, 4, 6, and 8)
- Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale(Baseline, Weeks 1, 2, 3, 4, 6 and 8)
研究者
研究点 (3)
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