Efficacy of olanzapine combined with megestrol acetate vs olanzapine alone when added to nutritional advice in reducing anorexia in patients undergoing chemotherapy for advanced hepato-pancreato-biliary tract, lung and genitourinary cancer - A randomized double-blind placebo controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Weight gain
研究概览
简要总结
When people have cancer, they often lose their appetite and lose weight. This happens because the cancer and the treatments like chemotherapy can affect the body in ways that make eating less appealing. This loss of appetite is called cancer- associated anorexia.
It is a bigger problem for some types of cancer, like cancers of the stomach or lungs, where up to 80% or 60% of patients can experience this issue. Doctors have found that some medications can help with this problem. Two that are known to work are megestrol acetate and corticosteroids. However, corticosteroids can have side effects like making infections more likely, so they're not always the best choice, especially for patients undergoing chemotherapy.
One interesting option being studied is olanzapine, which is a medication used for mental health conditions but also affects certain receptors in the body that can help control feelings of nausea and vomiting. This might make it useful for managing cancer-related loss of appetite and other symptoms. Studying how olanzapine works in cancers like lung, liver, gallbladder, genitourinary cancers could help doctors find better ways to help patients feel better and stay healthier during their cancer treatments.
Aim of the study: To compare the efficacy of Megestrol acetate combined olanzapine vs olanzapine alone in reducing anorexia in patients undergoing chemotherapy for hepatopancreatobiliary tract, lung and genitourinary cancer.
Objectives of the study: Effect of megestrol acetate combined olanzapine vs olanzapine alone on weight gain in patients undergoing chemotherapy for hepatopancreatobiliary tract, lung and genitourinary cancer. Changes in quality of Life, Side effect profile of the intervention and to understand the adverse events,Stratification anorexia in G.I. and other cancer, Control of symptoms of anorexia by assessing FAACT-ACS, and VAS score, Side effect profile of the intervention Change in biochemical profile after intervention.
Implications of The Study: Studying megestrol acetate combined with olanzapine versus olanzapine alone in cancer patients undergoing chemotherapy could offer important insights for improving treatment strategies, focusing on reducing appetite loss and enhancing overall well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Advanced hepato-pancreato-biliary tract, lung and genitourinary cancer and fit for chemotherapy.
- •Those who were willing to participate (via written consent form) in the study
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •Patients taking oral diet.
排除标准
- •Use of corticosteroids (except pre and post medication of chemotherapy)
- •Use of systemic corticosteroids (prednisolone 5mg or equivalent for more than 7 days in the previous 4 weeks) 3.Renal and/or hepatic dysfunction (Creatinine clearance ≤ 50ml/min, AST and ALT ≥ 3 times of upper limit of normal value, Total bilirubin ≥ 3mg/dl)
- •On any antipsychotic or antidepressants
- •Patients with concurrent radiotherapy
- •Mechanical obstruction of the gastrointestinal tract
- •Refractory ascites
- •Pregnancy and breast feeding
- •Diabetes mellitus (HbA1c ≥ 8%)
- •Head and neck cancer patients
- •Enrolled in another interventional trial
- •Patient require ryles tube insertion.
结局指标
主要结局
Weight gain
时间窗: 12 weeks
次要结局
- To compare between the 2 groups:(1. Changes in quality of Life)
研究者
Dr Anuj Gupta
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi