Breast cancer patients with high or low emitik conditions who are willing to apply the CBC2 Cannabis oil Breast cancer Microbiota Metabolites
Conditions
Interventions
The cannabis treatment (Deja Oil) group which will receive cannabis oil once per day. Deja Oil (CBD 0.6 ml/mg, THC 0.08 ml/drop, manufactured by the Herb and Thai Traditional Medicine Development Divi
Sponsors
Thai Traditional Medical Knowledge Fund
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-70 years old who were diagnosed with breast cancer; 2. Metastatic breast cancer patients who are currently receiving different doses of chemotherapy regimen with high/low emetic risk such as AC (cyclophosphamide and doxorubicin), AC followed by T (cyclophosphamide, doxorubicin, and paclitaxel), DC (cyclophosphamide and docetaxel), CMF (cyclophosphamide, fluorouracil, and methotrexate), and Paclitaxel; 3. Breast cancer patients at King Chulalongkorn Memorial Hospital (KCMH) from November 2022 to March 2023; 4. Participants provided written informed consent, 5. Individual has at least ESAS score more than and equal to 3.
Exclusion criteria
Exclusion criteria: 1. Women who have contraindications for chemotherapy such as anaphylaxis, 2. Women who have serious chemotherapy complications such as anaphylactic shock, bone marrow suppression, liver failure, acute kidney injury, and cardiac arrest, 3. Women who are scheduled elective surgery or other procedures requiring general anesthesia during the study, 4. Women who are in pregnant or lactating, and who are planned for pregnancy during the study, 5. Women who are terminally ill or inappropriate for placebo medication, 6. Women with any other significant disease or disorder which, in the opinion of the investigator, may have put the patient at risk because of participation in the study, or may have influence the result of the study, or the patients' ability to participate in the study, 7. Women with known history of substance abuse, 8. Women with history of cannabis ingredients allergy or suspected of having adverse reaction to cannabis, 9. Women using antibiotics within the past 3 months or using NSAIDs drugs, 10. Women consuming probiotic or prebiotic supplements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy 3 months ESAS | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 0, 1 months ESAS ,Efficacy 0, 1, 3 months EQ-5D-5L ,Safety 0,1,2,3 months Report the adverse event,Microbial alteration 0,3 months DNA extraction and PCR amplification for Nanopore MinION sequencing system,Cytokines changes 0,3 months ELISA method,Metabolites variation 0,3 months HPLC method,Pharmacokinetic analysis 0 months liquid chromatography-tandem mass spectrometry,Pharmacogenes analysis 0 months MassARRAY | — |
Countries
Thailand
Contacts
Public ContactKrit Pongpirul
Chulalongkorn University
Outcome results
None listed