NCT00637806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 Cancer of Multiple Types
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
- 4
- 试验地点
- 4
- 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
To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.
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
- •Cancer of multiple types in stage II, III, or IV and not a candidate for chemotherapy; but may have been receiving radiation therapy
- •Fair, poor, or very poor appetite
- •Cancer-associated anorexia/cachexia (documented weight loss of 2% over the prior week, or at least 5% within past 30 days, or at least 7.5% over prior 3 months, or at least 10% over prior 6 months)
- •Weight loss perceived to be associated with diminished appetite
- •Eastern Cooperative Oncology Group Performance score of 0, 1, or 2
- •Life expectancy greater than 3 months
- •Alert and mentally competent to complete study assessments
- •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 tumors that may interfere with food consumption
- •AIDS-related wasting
- •Radiation therapy to head and neck, abdomen, or pelvis within past 6 weeks, or for whom radiation therapy is anticipated during the study such that the result may interfere with food consumption
- •Presence of conditions that interfere with oral intake or ability to swallow
- •Absence of normally functioning gut
- •Known mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome
- •Intractable or frequent vomiting
- •Clinically significant diarrhea
- •History of thromboembolic events, or on long-term anticoagulation for thromboembolism
- •Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism
- •Poorly controlled hypertension or congestive heart failure
- •Pregnant/lactating females, or planning on becoming pregnant
- •Use of appetite stimulants within past 30 days
- •Use of parenteral nutrition or tube feedings within past 1 week
- •Chronic use of steroids within past 3 months (intermittent short-term use allowed)
- •Current use of illicit substances
- •Allergy, hypersensitivity, or other contraindication to megestrol acetate
研究组 & 干预措施
3
Placebo Comparator
干预措施: Placebo (Drug)
1
Active Comparator
Megestrol acetate concentrated suspension 110 mg/mL
干预措施: Megestrol acetate concentrated suspension 110 mg/mL (Drug)
2
Active Comparator
Megestrol acetate concentrated suspension 60 mg/mL
干预措施: Megestrol acetate concentrated suspension 60 mg/mL (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
- 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)
- Change in Weight Over the Course of the 8-week Double-blind Phase(Baseline, Week 1, 2, 3, 4, 6, and 8)
- 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)
研究者
研究点 (4)
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