To evaluate effects of THC:CBD (1:1) oil in reducing nausea score in gynecologic cancer patients who received moderate to high emetic risk chemotherapy. CINV, THC, CBD, Cannabis
Conditions
Interventions
THC:CBD 1:1 extract oil,THC:CBD extract oil 1:1, manufactured by Government Pharmaceutical Organization (GPO) of Thailand in 5 ml droplet bottle form. One drop containing THC 0.5 mg and CBD 0.5 mg. Pl
Placebo Comparator Drug,Placebo Comparator Drug
THC:CBD 1:1 extract oil,THC:CBD 1:1 extract oil
Sponsors
Bhumibol Adulyadej hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 18 years old or older ECOG ranging from 0 to 2 Gynecologic malignant patients who were treated with moderate and high emetic risk chemotherapy informed consent was obtained
Exclusion criteria
Exclusion criteria: 1.Any contraindications to cannabis oil extracts such as cardiovascular disease, history of substance abuse, epilepsy or recurrent seizures, history of psychiatric disorders, vehicle driving or working with machines cannot be refrained 2.Neurological disease or gastrointestinal obstruction with nausea-induced and/or vomiting, where anti-nausea and vomiting drugs are needed regularly 3.Persons who have been irradiated the brain, stomach and pelvic floor during the week before participating in the research or need to irradiate during the research 4.History of using cannabis extract 30 days before participating in the research 5.History of allergies to cannabis or cannabis extract 6.Pregnancy, breastfeeding, and unable to contracept women 7.Serum creatinine > 2 8.AST, ALT > 2.5 times over normal limits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nausea score Day 1 - day 5 Mean | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects Day 1 - day 5 percent | — |
Countries
Thailand
Contacts
Public ContactApichaya Sukpiriyagul
Bhumibol Adulyadej Hospital
Outcome results
None listed