An Efficacy Study Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients With Advanced Stage Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.
详细描述
Olanzapine and Mirtazapine have been used in the past few years to attempt to prevent weight and appetite loss in cancer patients. Both have mixed study results and none of the previous studies are of high enough quality to make clinical recommendations. With limited options available, palliative and oncology providers turn to these medications with little evidence. There are no formal studies comparing the two to determine if one is superior to the other, so choices are often made based purely on provider preference. We aim to conduct a study to determine if one of the drugs outperforms the other to guide our standard practice at Englewood Health. This study is being conducted to determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.
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
- None
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
- •• 18 years of age or older
- •Able to provide informed consent
- •Pathologically and/or clinically confirmed diagnosis of advanced cancer
- •At any point of treatment with standard chemotherapy*
- •o Scheduled to start, have discontinued or completed, or currently receiving
- •Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation
- •o Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2-week period).
- •Life expectancy of at least 4 months
- •Able to communicate well and comply with study requirements, including by phone and written logs
- •Patients on Dexamethasone will be allowed
排除标准
- •• Abnormal liver function defined as > twice upper limit of normal
- •Elevated QTc
- •o EKG performed within 1 year of enrollment will be accepted
- •Total parental nutrition (TPN) or enteral feeds (PEG/PEJ) for >70% of their primary source of daily calorie intake
- •Taking Marinol within 2 week of enrollment onto study
研究组 & 干预措施
Olanzapine
干预措施: Olanzapine (Drug)
Mirtazapine
干预措施: Mirtazapine (Drug)
结局指标
主要结局
Weight
时间窗: 6 months
Patients will have their weight measured every month. A ratio of 5% weight gain or weight stabilization over time will be used to determine if the medication is making an impact.
次要结局
- Quality of Life of patient(6 months)