Medicinal CANnabis (CBD/THC) to prevent the symptoms and side effects of chemotherapy in people with advanced CANcer (CANCAN): protocol for a phase II, randomised, double-blind, placebo-controlled trial

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dc.contributor.authorBellas, O.M.
dc.contributor.authorCao, K.
dc.contributor.authorBowen, J.
dc.contributor.authorSmid, S.
dc.contributor.authorShakib, S.
dc.contributor.authorCrawford, G.B.
dc.contributor.authorZannettino, A.
dc.contributor.authorYeung, D.T.
dc.contributor.authorKichenadasse, G.
dc.contributor.authorBoublik, J.
dc.contributor.authorLouise, J.
dc.contributor.authorMarker, J.
dc.contributor.authorCambareri, B.
dc.contributor.authorPrice, T.
dc.contributor.authorWardill, H.R.
dc.date.issued2025
dc.description.abstractIntroduction: Many chemotherapy agents used to treat advanced cancer are inherently mucotoxic, causing breakdown of the gastrointestinal mucosa (gastrointestinal mucositis (GI-M)) and lead to a constellation of secondary complications including diarrhoea, malnutrition, anorexia, pain, fatigue and sleep disturbances. These symptoms are usually managed individually, leading to polypharmacy and its associated risks. The endocannabinoid system regulates numerous biological and behavioural processes associated with chemotherapy side effects, suggesting its modulation could control these symptoms. Therefore, the CANnabinoids in CANcer (CANCAN) therapy trial is a phase II, randomised, double-blind, placebo-controlled trial that aims to determine the efficacy of medicinal cannabis in minimising GI-M and its associated symptom burden. Methods and analysis: The CANCAN trial is being conducted at four Australian sites: the Royal Adelaide Hospital, the Queen Elizabeth Hospital, Flinders Medical Centre and the Lyell McEwin Hospital. Adults (n=176) diagnosed with a solid tumour or a haematological cancer scheduled to receive mucotoxic chemotherapy will be eligible. Participants will be randomised 1:1 to receive either the investigational product (IP) or placebo, both delivered as sublingual wafers. The active IP contains cannabidiol (300 mg/day) and Δ9-tetrahydrocannabinol (5–20 mg/day, titrated by the participant). The primary outcome is GI-M burden, determined by the Mucositis Daily Questionnaire. Secondary and tertiary outcomes include overall symptom burden (Edmonton Symptom Assessment Scale), anorexia (Average Functional Assessment of Anorexia/Cachexia Therapy), depression/ anxiety (Hospital Anxiety and Depression Scale), financial toxicity (Functional Assessment of Chronic Illness Therapy COmprehensive Score for financial Toxicity), quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire), incidence of chemotherapy dose reductions/modifications, cumulative dose of chemotherapy administered, incidence/length of hospitalisation, the use of supportive care, and the cost-benefit of the IP. The CANCAN trial prioritises patient experiences by focusing on patient-reported outcome measures and administering medicinal cannabis during active treatment to prevent symptoms that occur secondary to mucositis. Ethics and dissemination: The protocol has been approved by Central Adelaide Local Health Network Human Research Ethics Committee (2022HRE00037). All participants will be required to provide written or digitally authorised informed consent. Trial results will be disseminated in peer-reviewed journals, and at scientific conferences. Trial registration number: ACTRN12622000419763.
dc.description.statementofresponsibilityOlivia M Bellas, Katrina Cao, Joanne Bowen, Scott Smid, Sepehr Shakib, Gregory B Crawford, Andrew Zannettino, David T Yeung, Ganessan Kichenadasse, Jarosalv Boublik, Jennie Louise, Julie Marker, Bronwyn Cambareri, Timothy Price, Hannah R Wardill
dc.identifier.citationBMJ Open, 2025; 15(3):e089336-1-e089336-10
dc.identifier.doi10.1136/bmjopen-2024-089336
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.orcidBellas, O.M. [0000-0002-7067-6925]
dc.identifier.orcidCao, K. [0000-0001-9710-0902]
dc.identifier.orcidBowen, J. [0000-0003-0876-0031]
dc.identifier.orcidSmid, S. [0000-0003-4192-7219]
dc.identifier.orcidShakib, S. [0000-0002-7199-5733]
dc.identifier.orcidCrawford, G.B. [0000-0001-7347-8855]
dc.identifier.orcidZannettino, A. [0000-0002-6646-6167]
dc.identifier.orcidYeung, D.T. [0000-0002-7558-9927]
dc.identifier.orcidLouise, J. [0000-0001-5785-0290]
dc.identifier.orcidPrice, T. [0000-0002-3922-2693]
dc.identifier.orcidWardill, H.R. [0000-0002-6613-3661]
dc.identifier.urihttps://hdl.handle.net/2440/144727
dc.language.isoen
dc.publisherBMJ Publishing Group
dc.rights© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
dc.source.urihttps://doi.org/10.1136/bmjopen-2024-089336
dc.subjectMedicinal CANnabis
dc.subject.meshHumans
dc.subject.meshNeoplasms
dc.subject.meshCannabidiol
dc.subject.meshAntineoplastic Agents
dc.subject.meshDouble-Blind Method
dc.subject.meshQuality of Life
dc.subject.meshAdult
dc.subject.meshAustralia
dc.subject.meshFemale
dc.subject.meshMale
dc.subject.meshMucositis
dc.subject.meshMulticenter Studies as Topic
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshClinical Trials, Phase II as Topic
dc.subject.meshDronabinol
dc.subject.meshMedical Marijuana
dc.titleMedicinal CANnabis (CBD/THC) to prevent the symptoms and side effects of chemotherapy in people with advanced CANcer (CANCAN): protocol for a phase II, randomised, double-blind, placebo-controlled trial
dc.typeJournal article
pubs.publication-statusPublished

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