The Effect of Medical Cannabidiol on Lean Body Mass in Patients Receiving Oxaliplatin or Paclitaxel Based Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of patients with change in lean body mass from baseline.
研究概览
简要总结
An intervention study on the effect of cannabidiol on lean body mass in cancer patients receiving chemotherapy, at the department of Clinical Oncology at Zealand University Hospital, Roskilde, Denmark. Fat free mass will be measured by bioimpedance spectroscopy. As secondary outcomes protein and energy intake, nausea, taste alterations and life quality will be assessed by oral interviews and questionnaires.
详细描述
One of the side effects of chemotherapy is loss of lean body mass. With a non-blinded two armed intervention design this study will examine the effect of cannabidiol on fat free mass in cancer patients. The study will include patients who are diagnosed with cancer and scheduled to undergo at least 4 courses of paclitaxel or oxaliplatin based chemotherapy.
The hypothesis is that patients receiving cannabidiol (300mg/day) will have no change in lean body mass at the end of the study. In extension to this, we hypothesize that cannabidiol will increase the energy and protein intake because of increased appetite and decreased nausea and emesis.
Recruitment and data collection will take place at the department of Clinical Oncology at Zealand University Hospital, Roskilde.
Each patient will be included for four courses of paclitaxel or oxaliplatin based chemotherapy. The length between each chemotherapy course is three weeks.
Lean body mass will be measured by impedance spectroscopy before every chemotherapy treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Control group will enter this study if not wanting to participate in cannabidiol study. Due to this masking is not possible.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of cancer
- •Fulfill criteria for starting chemotherapy
- •Must be able to stand upright
- •Have the possibility of contact by telephone
- •No previous treatment with taxanes or platinums
- •Scheduled to undergo lest 4 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy
- •If female and fertile, must have been menopausal for 1 year or negative pregnancy test at inclusion and use approved contraceptive measures
排除标准
- •Breastfeeding
- •Unable to complete patient reported outcomes (PRO)-measurements
- •Previously received taxanes or platinum-based chemotherapy
- •Use of cannabinoids. If in use, treatment must be stopped 4 days prior to inclusion
- •If using any anti epileptic or antidepressant medicine. Treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. However, any treatment with Clobazam is not allowed due to major interaction with cannabidiol.
研究组 & 干预措施
Intervention group
Cancer patients receiving cannabidiol
干预措施: Cannabidiol (Drug)
结局指标
主要结局
Number of patients with change in lean body mass from baseline.
时间窗: 10 weeks
Changes in lean body mass measured at baseline and before each chemotherapy treatment (scheduled for every three weeks) measured in kg by bioimpedance. Changes are assessed as change in percentage of total lean body mass weight.
次要结局
- Change in nausea(10 weeks)
- Change in food intake(10 weeks)
- Change in energy intake .(10 weeks)
- Change in protein intake(10 weeks)
- Difference in taste during chemotherapy.(10 weeks)
- Change in emesis(10 weeks)
- Change in appetite(10 weeks)
- Change in Quality of life (QOL)(10 weeks)
研究者
Jens Rikardt Andersen
Associate professor
University of Copenhagen