A randomised, double blind, placebo controlled trial of megestrol acetate suspension with olanzapine or olanzapine with placebo in treating symptomatic anorexia in people with advanced cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 1. To compare gain in weight in advanced malignancies with cancer related anorexia in two arms: a.Megesterol acetate and olanzapine. b. olanzapine plus placebo
研究概览
简要总结
Cancer-related anorexia (CRA) affects 40%-60% of patients who have been newly diagnosed with cancer. It is associated with decreased appetite, early satiety, alterations in taste, reduced performance status, and a lower quality of life (QOL). It leads to insufficient oral intake, compromising cancer survival. Current guidelines for the treatment of anorexia and cachexia recommend dietary counselling, and it will be the initial step of nutritional support that will be offered to cancer patients who are cachectic or at-risk patients who can eat. Common pharmaco-therapeutic agents used for CRA are Corticosteroids, mirtazapine, olanzapine, and megestrol acetate. Olanzapine has showed a good effect in reducing nausea and increased oral intake, it can be considered as the current standard of care for treating CRA.
Hypothesis/ Research question
We hypothesize that the addition of Megesterol acetate to olanzapine in patients with cancer related anorexia will improve appetite and will lead to gain in weight compared with olanzapine alone.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically or cytologically confirmed advanced cancer, treated with palliative cytotoxic chemotherapy 2) Eastern cooperative oncology group perfromance status (ECOG PS) of 0 to 3 3) Age 18years and above 4) Patient taking an oral diet 5) Normal renal and hepatic function.
排除标准
- •Patients diagnosed with Carcinoma Breast 2)Patients planned for or on Targeted therapy, or Immunotherapy, or Oral metronomic chemotherapy 3)Patients with concurrent radiotherapy 4)Pregnant or breastfeeding women 5)Persistent and uncontrolled nausea and/or vomiting 6)Active gastrointestinal tract obstruction 7)Patients allergic to the drugs being tested.
结局指标
主要结局
1. To compare gain in weight in advanced malignancies with cancer related anorexia in two arms: a.Megesterol acetate and olanzapine. b. olanzapine plus placebo
时间窗: 12 weeks
2. To compare improvement in appetite in advanced malignancies with cancer related anorexia in two arms: a.Megesterol acetate and olanzapine. b. olanzapine plus placebo
时间窗: 12 weeks
次要结局
- To compare between the 2 arms:(a. Change in quality of life (QOL))
研究者
SOURAV KUMAR MISHRA
AIIMS Bhubaneswar