olanzapine versus megastrol acetate in treating loss of appetite in patients with cancer undergoing chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To find out the effective agent that can prevent cachexia/anorexia associated with chemotherapy
研究概览
简要总结
Olanzapine, an atypical antipsychotic, and Megestrol acetate,a synthetic progestin, exert their effects through different mechanisms, potentially offering complementary or distinct benefits in appetite stimulation.
While both drugs have demonstrated efficacy in improving appetite and quality of life in cancer patients, comparative studies are sparse, making it essential to evaluate their relative effectiveness in this context.
Identifying which drug offers better appetite improvement with fewer adverse effects can aid clinicians in tailoring treatment strategies to individual patient needs, ultimately optimizing symptom management and overall treatment outcomes.
PRIMARY OBJECTIVE:
To determine whether olanzapine leads to greater appetite improvement from baseline in cancer patients suffering from anorexia compared to megestrol acetate using the 0-10 numerical rating scale (NRS)
SECONDARY OBJECTIVE:
· To determine whether olanzapine leads to a greater proportion of patients who report a 5% or greater weight gain from baseline compared to megestrol acetate.
- To compare change in cachexia/anorexia symptoms with olanzapine compared to megestrol acetate using the Functional Assessment of anorexia/cachexia treatment (FAACT)-Anorexia/Cachexia Subscale (A/CS)instrument
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All stage 3 and 4 GI and lung cancer patients.
排除标准
- •Cancer patient who are on longterm steroid pregnancy.
结局指标
主要结局
To find out the effective agent that can prevent cachexia/anorexia associated with chemotherapy
时间窗: To find out the effective agent that can prevent cachexia/anorexia associated with chemotherapy
次要结局
- To determine whether olanzapine leads to a greater proportion of patients who report a 5% or greater weight gain from baseline compared to megestrol acetate.
研究者
Dr K Pavithran
Amrita institute of medical science