Oral THC:CBD cannabis extract adjuvant for reducing chemotherapy-induced nausea and vomiting: A randomized, double-blind, placebo-controlled, cross over trial
- Conditions
- 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
- Registration Number
- TCTR20220829003
- Lead Sponsor
- Bhumibol Adulyadej hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 86
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ausea score Day 1 - day 5 Mean
- Secondary Outcome Measures
Name Time Method Side effects Day 1 - day 5 percent