Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- ESAS-TSDS score
研究概览
简要总结
The goal is to explore whether the application of cannabis extract Avextra 10/10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.
详细描述
170 oncological patients in palliative treatment will be randomized 1:1 to an THC:CBD-interventional arm and an placebo-arm. At the timepoints baseline, 12±2 days, 18±3 days, four weeks and eight weeks, the global burden of symptoms (ESAS TSDS), quality of life (EORTC QLQ C15 PAL) and other parameter will be measured and the intraindividual difference in comparison with the baseline will be compared between the groups. This study is intended to provide a significant contribution to Evidence-based medicine (EbM) of CAM in palliative medicine as well as for elderly and severely ill subjects (resp.) in general.
The following gain of knowledge is expected:
- substancial and reliable effects of CAM in elderly subjects being in a multimorbid and psychologically very stressful situation of illness and life (resp.).
- substancial and reliable effects of CAM in aduld subjects being in a oncologically and palliative situation of illness and life (resp.).
- compatibility of a CAM-therapy in multimorbid patients with polypharmacotherapy.
- importance of CAM for the very frequent psychovegetative disturbance and comorbidities of many illnesses like sleepnesness, loss of appetite, nausea, fear and affective disturbance.
- possible reduction of costs and improved economics through CAM
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
IMPs are centrally blinded and randomised at the pharmacy.
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥25 years old and legally competent
- •Palliative oncological therapy
- •ECOG status 1, 2 or 3, incapacitated for work
- •ESAS TSDS > or equals 16
- •Nutritional Risk Screening > or equals 3
- •Pain numerical rating scale > or equals 4
- •informed consent
- •for WOCBP:
- •Negative pregnancy test
- •Reliable contraception (Pearl Index < 1%)
排除标准
- •nausea > or equals grade 3 (CTCAE) or vomiting > or equals grade 2 (CTCAE) in the preceding week
- •Inability to understand and complete the questionnaires
- •Cannabis use in the last 6 weeks
- •Alcohol addiction
- •Pregnancy/lactation
- •Contraindications or intolerance to the study medication (esp. psychosis)
- •Simultaneous participation in other clinical studies (sumulataneous participation in non-interventional studies (i.e. biomarker-studies, registries) is allowed, if the study-aim does not interfere with measures of the second study)
- •Any other condition as judged by the investigator, e.g. non-compliance
研究组 & 干预措施
Cannabisextrakt Avextra 10/10 Lösung
Solution with tetrahydrocannabinol and cannabidiol
干预措施: Cannabisextrakt Avextra 10/10 Lösung (Drug)
Placebo
Sesame oil, Ph.Eur. Linseed oil, Ph.Eur
干预措施: Cannabisextrakt Avextra 10/10 Lösung (Drug)
结局指标
主要结局
ESAS-TSDS score
时间窗: 12 days
Symptom change as percentage change in ESAS-TSDS score after 12±2 days compared to baseline between intervention group and placebo control group.
次要结局
- Global Patient's Assessment(12 days, 4 weeks, 8 weeks)
- opioid dose as morphine equivalent(12 days, 4 weeks, 8 weeks)
- defined daily dosages (DDD) of neuropharmaceuticals(12 days, 4 weeks, 8 weeks)
- ESAS-TSDS score(4 weeks, 8 weeks)
- inappetence(12 days, 4 weeks, 8 weeks)
- NCCN distress thermometer(12 days, 4 weeks, 8 weeks)
- pain as VAS(12 days, 4 weeks, 8 weeks)
- sleep quality (Pittsburgh Sleep Quality Index, PSQI)(12 days, 4 weeks, 8 weeks)
- EORTC QLQ-C15 PAL(12 days, 4 weeks, 8 weeks)
- Adverse events (AE)(up to 8 weeks)
- C-reactive protein (CRP)(12 days, 4 weeks, 8 weeks)
- all endpoints stratified by stage of oncological disease (ICD-10), treatment modalities, gender, weight, high/low dose, renal function and age whereever possible and meaningful(12 days, 4 weeks, 8 weeks)