TCTR20210712003尚未招募3 期
The study evaluating the efficacy, safety and economic evaluation of Thai medical marijuana products
Dr. Pongtorn Chantharatsami0 个研究点目标入组 668 人开始时间: 2021年7月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 668
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 25 Years 至 100 Years(—)
- 性别
- All
入选标准
- •1. Patient with metastatic cancer or incurable cancer whom was confirmed diagnosis by histology or radiology
- •2. Patient who receives best supportive care, palliative care, or other non-curative therapy including: palliative chemotherapy, palliative radiation therapy, targeted therapy, hormonal therapy, and palliative surgery
- •3. Patient who has symptoms or applies any medication in order to improve pain, nausea/vomiting, insomnia, or loss of appetite.
- •4. age 25 years and older
- •5. No previous medical marijuana administration at least 3 weeks prior to enrollment, if not, after stop medical marijuana at least 3 weeks, re-inclusion will be considered.
- •6. PPS >= 40
- •7. For female participants in reproductive age, urine pregnancy test must be negative and contraception must be consented prior to enrollment.
- •8. For male participant, contraception must be consented and sperm donation during the study is not allowed.
排除标准
- •Patient who has the following:
- •1. Continuing curative therapy, including: surgery, radiation, chemotherapy
- •2. Severe symptoms of unstable cardio-pulmonary disease, including: angina, peripheral vascular disease, cerebrovascular disease, and arrhythmia
- •3. History of psychosis, schizophrenia, or substance use disorder (alcohol, amphetamine, cocaine, except tobacco and caffeine)
- •4. History of allergic reaction to medical marijuana product or its component
- •5. Liver impairment including: cirrhosis, or elevated liver enzyme ( AST, ALT) more than 3 times of upper normal limit
- •6. End-stage renal disease
- •7. Pregnancy of breastfeeding woman
- •8. Taking the following medication, which has drug interaction with marijuana: warfarin, rivaroxaban, apixaban, clopidogrel, cilostazol, phenytoin, carbamazepine, phenobarbital, perampanel, propranolol, metoprolol, bisoprolol, norfloxacin, ciprofloxacin, levofloxacin, amlodipine, nifedipine, and fluoxetine
- •9. Not mindful or lack of capacity to answer questionnaires
- •10. Can not communicate in Thai
研究者
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