RecruitingPhase 2ACTRN12622000419763

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


Sponsor

Central Adelaide Local Health Network (CALHN)

Enrollment

176 participants

Start Date

Feb 1, 2025

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Chemotherapy is a powerful but often brutal treatment for cancer. Side effects like nausea, diarrhoea, poor appetite, pain, poor sleep, and anxiety can be severe enough to interrupt treatment or reduce the dose — directly affecting how well the cancer is controlled. Medicinal cannabis, combining CBD and THC, has shown early promise in managing some of these side effects. The CANCAN trial is a rigorous Australian study testing whether a combination of CBD (400mg/day) and low-dose THC given in capsule form during chemotherapy cycles helps reduce gut symptoms, improves food intake, sleep, and quality of life, and allows patients to complete their planned treatment. Half of participants will receive the active cannabis capsules and half will receive a placebo. You may be eligible if you are 18 or older and are scheduled to receive at least 3 cycles of chemotherapy for a solid tumour cancer, or an autologous stem cell transplant for a blood cancer. People with cannabis dependence, a history of psychosis or certain psychiatric conditions, serious heart disease, pregnancy, or significant liver disease are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 incr

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)

The Royal Adelaide Hospital - Adelaide

SA, Australia

The Queen Elizabeth Hospital - Woodville

SA, Australia

Flinders Medical Centre - Bedford Park

SA, Australia

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ACTRN12622000419763