The study evaluating the efficacy, safety and economic evaluation of Thai medical marijuana products
- Conditions
- Efficacy and safety of 2 different Thai medical marijuana products compared to placebo in palliative care patientsEconomic cost and benefit of Thai marijuana productsMarijuanaCBDTHCCannabinoidCannabidolCanabisPalliativeSupportiveAdvance-stage
- Registration Number
- TCTR20210712003
- Lead Sponsor
- Dr. Pongtorn Chantharatsami
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 668
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life 3 months EQ-5D-5
- Secondary Outcome Measures
Name Time Method Quality of life 3 months ESAS,Sleep quality 3 months questionnaire,Frequency of hospitalization and pain killer administration 3 months medical record,Death 3 month house hold registration,self health 3 months self-health assessment, 0-100