Introduction Chemotherapy-induced nausea and vomiting (CINV) remains an important issue for patients receiving chemotherapy despite guideline-consistent antiemetic therapy. Trials using delta-9-tetrahydrocannabinol-rich (THC) products demonstrate limited antiemetic effect, significant adverse events and flawed study design. Trials using cannabidiol-rich (CBD) products demonstrate improved efficacy and psychological adverse event profile. No definitive trials have been conducted to support the use of cannabinoids for this indication, nor has the potential economic impact of incorporating such regimens into the Australian healthcare system been established. CannabisCINV aims to assess the efficacy, safety and cost-effectiveness of adding TN-TC11M, an oral THC/CBD extract to guideline-consistent antiemetics in the secondary prevention of CINV.
Methods and analysis The current multicentre, 1:1 randomised cross-over, placebo-controlled pilot study will recruit 80 adult patients with any malignancy, experiencing CINV during moderate to highly emetogenic chemotherapy despite guideline-consistent antiemetics. Patients receive oral TN-TC11M (THC 2.5mg/CBD 2.5 mg) capsules or placebo capsules three times a day on day −1 to day 5 of cycle A of chemotherapy, followed by the alternative drug regimen during cycle B of chemotherapy and the preferred drug regimen during cycle C. The primary endpoint is the proportion of subjects attaining a complete response to CINV. Secondary and tertiary endpoints include regimen tolerability, impact on quality of life and health system resource use. The primary assessment tool is patient diaries, which are filled from day −1 to day 5. A subsequent randomised placebo-controlled parallel phase III trial will recruit a further 250 patients.
Ethics and dissemination The protocol was approved by ethics review committees for all participating sites. Results will be disseminated in peer-reviewed journals and at scientific conferences.
Drug supply Tilray.
Protocol version 2.0, 9 June 2017.
Trial registration number ANZCTR12616001036404; Pre-results.
- chemotherapy-induced nausea and vomiting
- randomized trial
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Contributors PG, PSH, MS, NL, JS, IM, IO, DJA, CG and ACK were responsible for study concept (grant authors). PG, PSH, MS, NL, JS, IM, IO, DJA, CG, ACK, RLM and NW were responsible for protocol development. PG, AT, AJM, NW, AW, CH, ACK, MS, CG, PF, SC, KB and MA were responsible for study conduct.
Funding NSW Department of Health, drug supply by Tilray.
Competing interests None declared.
Patient consent Not required.
Ethics approval This protocol was approved at the Sydney Local Health District ethics review committee (Royal Prince Alfred Hospital zone) and ethics review committees for all participating sites.
Provenance and peer review Not commissioned; externally peer reviewed.