Comparison of Olanzapine and Mirtazapine on Cancer Associated Anorexia and Cachexia Syndrome in Advanced Cancer Patients: An Open Label, Prospective, Comparative, Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
研究概览
简要总结
This prospective, open-label, comparative interventional study aims to evaluate and compare the efficacy and safety of olanzapine and mirtazapine in managing cancer-associated anorexia and cachexia syndrome (CACS) among advanced cancer patients at J.L.N. Medical College, Ajmer. A total of 140 participants will be randomly assigned equally into two groups, receiving either olanzapine 5 mg/day or mirtazapine 15 mg/day for 28 days. The primary outcome is the mean change in body weight at 2 and 4 weeks. Secondary outcomes include effects on anxiety, depression (HADS), sleep quality (LSEQ), and nausea/vomiting (VAS). Statistical significance will be assessed at p less than 0.05 to determine comparative efficacy and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years and above.
- •Registered in the palliative care centre.
- •Suffering from histologically diagnosed advanced cancer (Cancer with metastasis).
- •Patients with a weight loss of more than 5 percent of body weight over the past 6 months or loss of 2-5 percent of body weight over the past 6 months plus Body Mass Index (BMI) of less than
- •Loss of appetite score (SNAQ score less than 14).
- •Patient giving written informed consent for this Study.
排除标准
- •Pregnant and lactating female.
- •Known history of hypersensitivity to study drugs.
- •Severe renal impairment (creatinine more than 2).
- •Severe liver impairment (Child Pugh score more than 10).
- •Significant disorder of bone marrow.
- •Severe cardiac impairment.
- •Patient taking antipsychotic, sedative psychotropic drug, atropine, and its substitute.
- •Non cooperative patient.
研究者
Dr Arun Kumar Garg
JLN Medical College, Ajmer