Investigating the effect of medicinal cannabis on the symptoms and side effects of chemotherapy in people with cancer.
The CANnabinoids in CANcer (CANCAN) trial: Investigating the effect of medicinal cannabis on symptoms and side effects of chemotherapy in people with cancer
Central Adelaide Local Health Network (CALHN)
176 participants
Feb 1, 2025
Interventional
Conditions
Summary
The CANCAN trial aims to provide the evidence needed to better inform healthcare professionals in the use of medicinal cannabis in people with cancer. The purpose of this study is to investigate whether medicinal cannabis – a combination of cannabidiol (CBD) and tetrahydrocannabinol (THC) – is effective and safe for the management of chemotherapy symptoms and side effects in people receiving treatment for cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are scheduled to undergo either at least 3 cycles of chemotherapy for treatment of a solid tumour, or autologous stem cell transplantation for treatment of a haemotological cancer. Study details Participants will be randomised (i.e. allocated by chance) to receive either the medicinal cannabis treatment or a placebo. Participants in the medicinal cannabis group will receive 400mg per day of CBD and a starting dose of 2.5mg per day of THC in the form of an oral capsule for the duration of each treatment cycle, while participants in the placebo group will receive a daily glucose capsule. All participants will be monitored for symptoms of gut distress, have blood tests and their body weight taken, and answer a number of questionnaires, to determine if the medicinal cannabis treatment has an effect on chemotherapy symptoms and side effects for up to 6 months after the completion of treatment. Participants will also be monitored over this period for whether they have used supportive care or been hospitalised, for whether they have completed or ceased treatment and why, for their response to chemotherapy, and for any adverse events. It is hoped that this study may show that medicinal cannabis will minimise the intensity of chemotherapy symptoms, and thus have beneficial effects on the outcomes of chemotherapy. Specifically, we anticipate that CBD will minimise gut injury, therefore minimising local symptoms including diarrhea, malabsorption and pain, while THC will promote food intake, improve sleep quality and decrease anxiety. We expect this to have benefits on quality of life, and the ability of participants to receive their intended dose of chemotherapy without interruptions.
Eligibility
Inclusion Criteria5
- years of age or older
- Scheduled to receive mucotoxic, systemic cancer therapy for advanced solid and haematological cancers.
- Anticipated to undergo 3 cycles of chemotherapy (solid tumour cancer participants) OR autologous stem cell transplantation (haematological cancers – HSCT participants).
- Willing to commit to not taking cannabis in any other form during the clinical trial period.
- For randomisation of solid tumour participants: Gut distress symptoms related to their cancer therapy defined by a score of greater or equal to 1 in the MDQ and confirmed by research nurse.
Exclusion Criteria12
- Cannabis dependence / misuse defined by the revised Cannabis Use Disorder Identification test score of 8 or above.
- History of unstable cardiovascular disease including myocardial infarction or cerebrovascular accident, crescendo history of angina or heart failure.
- Recreational or medicinal cannabis use defined as use >once/week in the month leading up to the clinical trial period.
- History of psychosis secondary to, or intolerance to cannabis products.
- Presence of an active psychiatric disorder or concurrent disorder that may be exacerbated by
- cannabinoids, or which may interfere with clinical trial outcome determination (determined by the recruiting clinician).
- Pregnant or planning on becoming pregnant.
- Currently lactating.
- Involved in another clinical trial (except observational trials) or expected to start one soon after completion.
- Pre-existing oral disease or disability that would impair oral-administration or mucosal absorption.
- Presence of known impairment of hepatic synthetic dysfunction.
- Laboratory values suggestive of liver dysfunction.
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Interventions
Brief name: Medicinal cannabis (Cannabidiol [CBD] and Tetrahydrocannabinol [THC]) Status: Unregistered drug CBD dose: 400 mg/day THC dose: 2.5-22.5mg/day (starting at 2.5mg increasing at 5mg increments until maximum tolerate dose is achieved in the absence of agitation and sedation (determined by Richmond Agitation and Sedation Scale); each participant escalates with support of nurse who then records final dose). Duration: 6-9 weeks depending on specifics of cancer treatment schedule Administration: Oral capsule with medicinal cannabis isolates in oil carrier Timing of intervention: Solid tumours - from mucositis daily questionnaire (MDQ) score >1 in first cycle of chemotherapy to end of cycle 3. Haematopoeitic stem cell transplant (HSCT) recipients - from day of admission (~day -7) to day +35. Adherence assessment: participant reported (daily confirmation of taking the capsule) and return of empty capsule packets to hospital pharmacy
Locations(3)
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ACTRN12622000419763