Efficacy of Cannabis Oil for Alleviating Side Effects of Breast Cancer Chemotherapy: A Randomized Double-blinded Controlled Trial

Phase 4

• Conditions: Breast cancer patients with high or low emitik conditions who are willing to apply the CBC2; Cannabis oil; Breast cancer; Microbiota; Metabolites

• Registration Number: TCTR20220809001
• Lead Sponsor: Thai Traditional Medical Knowledge Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-09
• Last Update Posted: 19 August 2024
• Study Completion: 2024-09-16

Recruitment & Eligibility

• Status: nknown
• Sex: Female
• Target Recruitment: 90

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy 3 months ESAS

Secondary Outcome Measures

Name	Time	Method
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