| MedCan Pilot | MedCan 1 | MedCan 2 |
---|---|---|---|
Objective | To investigate the feasibility of drawing on global symptom burden scales to assess response to cannabidiol (CBD) or tetrahydrocannabinol (THC) To determine median tolerated doses of CBD and THC To document adverse events | To assess the effect of escalating doses of CBD versus placebo in the management of symptom burden in patients with advanced cancer | To investigate the safety and efficacy of escalating doses of CBD/THC versus placebo for the management of symptom burden in patients with advanced cancer |
Design | Prospective two-arm open-label pilot trial | Multi-centre, blinded randomised placebo controlled trial | Multi-centre, blinded, randomised, placebo-controlled trial |
Trial interventions | Arm 1: escalating doses of CBD delivered orally via an oil. Arm 2: escalating doses of THC delivered orally via an oil. | Arm 1: Intervention: escalating doses of CBD delivered orally via an oil. Two-week patient-determined titration phase to reach symptom burden relief with tolerable side effects, followed by an optional 2 weeks of a stable dose. Arm 2: Placebo: matching placebo oil solution. | Arm 1: Intervention: escalating doses of THC and CBD delivered in a 1:1 ratio orally via an oil. Two-week patient-determined titration phase to reach symptom burden relief with tolerable side effects, followed by 2 weeks of a stable dose. Arm 2: Placebo: matching placebo oil solution. |
Primary outcomes | Number of participants screened and number of participants completing 14 and 28 days | Change in TSDS from baseline to day 14 | Change in TSDS from baseline to day 14 |
Trial status and registration | Complete: ACTRN12618001205224 Registered July 2018 (MedCan – Pilot) | Complete (under analysis): ACTRN12618001220257 Registered July 2018 (MedCan 1 – CBD) | Ongoing: ACTRN12619000037101 Registered January 2019 (MedCan – 2 THC/CBD) |
Ethical approval | HREC/18/MHS/83 | HREC/18/MHS/43; HREC 18/16 | HREC/MML/49348; HREC 18/36 |
Funder | NHMRC MRFF Grant APP1152232 | NHMRC MRFF Grant APP1140160 |