Efficacy and safety of 2 different Thai medical marijuana products compared to placebo in palliative care patients Economic cost and benefit of Thai marijuana products Marijuana
Conditions
Interventions
Decha regimen, manufactured by Department of Thai Traditional and Complementary Medicine, is composed of THC 0.08 mg/drop and CBC 0.02 mg/drop. Begin with 5 drops per oral at bedtime (0.4 mg/day) for
Experimental Drug,Experimental Drug,Placebo Comparator No treatment,Placebo Comparator No treatment
Marijuana oil, Decha regimen,Marijuana oil, GPO regiem,Decha placebo,GPO placebo
Sponsors
Dr. Pongtorn Chantharatsami
Eligibility
Sex/Gender
All
Age
25 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life 3 months EQ-5D-5L | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactChaisiri angkurawaranon
Family medicine department, Faculty of medicine, Chiang Mai University
Outcome results
None listed