Skip to main content
Canna~Fangled Abstracts

Efficacy and mechanisms of cannabis oil for alleviating side effects of breast cancer chemotherapy (CBC2): protocol for randomized controlled trial

By March 23, 2024No Comments

. 2024 Mar 23;24(1):130.

doi: 10.1186/s12906-024-04426-0.

May Soe Thu 1 2 3, Krit Pongpirul 4 5 6 7, Mawin Vongsaisuwon 8 9, Chanida Vinayanuwattikun 9 10, Kamonwan Banchuen 11 12, Thunnicha Ondee 3, Sunchai Payungporn 13, Phanupong Phutrakool 11 14, Preecha Nootim 12, Pajaree Chariyavilaskul 15, Sarocha Cherdchom 11, Kulthanit Wanaratna 12, Nattiya Hirankarn 2
Affiliations 

Abstract

Background: In a pilot study using both cannabidiol (CBD) and tetrahydrocannabinol (THC) as single agents in advanced cancer patients undergoing palliative care in Thailand, the doses were generally well tolerated, and the outcome measure of total symptom distress scores showed overall symptom benefit. The current study aims to determine the intensity of the symptoms experienced by breast cancer patients, to explore the microbiome profile, cytokines, and bacterial metabolites before and after the treatment with cannabis oil or no cannabis oil, and to study the pharmacokinetics parameters and pharmacogenetics profile of the doses.

Methods: A randomized, double-blinded, placebo-controlled trial will be conducted on the breast cancer cases who were diagnosed with breast cancer and currently receiving chemotherapy at King Chulalongkorn Memorial Hospital (KCMH), Bangkok, Thailand. Block randomization will be used to allocate the patients into three groups: Ganja Oil (THC 2 mg/ml; THC 0.08 mg/drop, and CBD 0.02 mg/drop), Metta Osot (THC 81 mg/ml; THC 3 mg/drop), and placebo oil. The Edmonton Symptom Assessment System (ESAS), Food Frequency Questionnaires (FFQ), microbiome profile, cytokines, and bacterial metabolites will be assessed before and after the interventions, along with pharmacokinetic and pharmacogenetic profile of the treatment during the intervention.

Trial registration: TCTR20220809001.

Keywords: Breast Cancer, Cannabis, Microbiota, Quality of Life

PubMed Disclaimer

References

    1. Hashemi SM, Balouchi A, Al-Mawali A, Rafiemanesh H, Rezaie-Keikhaie K, Bouya S, et al. Health-related quality of life of breast cancer patients in the Eastern Mediterranean region: a systematic review and meta-analysis. Breast Cancer Res Treat. 2019;174(3):585–96. – DOI – PubMed
    1. Yanez B, Thompson EH, Stanton AL. Quality of life among Latina breast cancer patients: a systematic review of the literature. J Cancer Surviv. 2011;5(2):191–207. – DOI – PubMed – PMC
    1. Paraskevi T. Quality of life outcomes in patients with breast cancer. Oncol Rev. 2012;6(1):e2. – DOI – PubMed – PMC
    1. Redeker NS, Lev EL, Ruggiero J. Insomnia, fatigue, anxiety, depression, and quality of life of cancer patients undergoing chemotherapy. Sch Inq Nurs Pract. 2000;14(4):275–90; discussion 91-8. – PubMed
    1. Mokhtari-Hessari P, Montazeri A. Health-related quality of life in breast cancer patients: review of reviews from 2008 to 2018. Health Qual Life Outcomes. 2020;18(1):338. – DOI – PubMed – PMC

Leave a Reply