Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- no greater than 5% weight loss in olanzapine 2.5 mg versus placebo
研究概览
简要总结
Cancer anorexia-cachexia syndrome is one of the common conditions in cancer patients. Olanzapine has been demonstrated to reduce chemotherapy-induced anorexia. However, there is scarce information regarding olanzapine as a treatment of cancer anorexia among patients who does not receive chemotherapy. Therefore, this randomized controlled trial aims to evaluate the efficacy of olanzapine to lessen cancer cachexia-anorexia syndrome.
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
- Triple (Participant, Care Provider, 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
- •pathologically or cytologically metastatic or locally advanced cancer
- •anorexia and >=5% weight loss during the past 6 months or anorexia with numerical scale of anorexia >=5
- •ECOG performance status 0-3
- •able to complete questionaire and able to swallow pills
排除标准
- •receiving chemotherapy or anti-cancer systemic therapy
- •life expectancy longer than 1 month
- •received radiotherapy at head/neck or thoracic or upper abdomen in the past 2 weeks
- •surgery within 4 weeks
- •pregnancy
- •serum bilirubin > 2 mg/dl or serum Cr > 2 mg/dl
- •current use of olanzapine or other antipsychotic drug
- •known cardiac arrhythmia, uncontrolled brain metastasis, history of seizure or acute coronary event in the past 6 months
研究组 & 干预措施
placebo
placebo 1 tablet/day for 28 days
干预措施: Placebo (Drug)
olanzapine 2.5
olanzapine 2.5 mg/day for 28 days
干预措施: Olanzapine 2.5 MG (Drug)
olanzapine 5
olanzapine 5 mg/day for 28 days
干预措施: Olanzapine 5 MG (Drug)
结局指标
主要结局
no greater than 5% weight loss in olanzapine 2.5 mg versus placebo
时间窗: 4 weeks
proportion of patients with olanzapine 2.5 mg without greater or equal to 5% weight loss compared to placebo
次要结局
- numerical scale of anorexia(4 weeks)
- adverse effects(week 1, 2, 3, 4)
- no greater than 5% weight loss in olanzapine 5 mg versus placebo(4 weeks)
- body weight(week 2 and 4)