Phase I/II Double-Blind, Randomized Controlled Trial of Medicinal Cannabis on Quality of Life and Symptoms in Advanced Cancer: RESONANCE Trial Protocol

Wong, AK; McMahon, WR; Grobler, A; Wilson, C; Martin, J; Galettis, P; Mitchell, P; Le, B; Philip, J; Gan, H; Cebon, J

Author(s): Wong, AK; McMahon, WR; Grobler, A; Wilson, C; Martin, J; Galettis, P; Mitchell, P; Le, B; Philip, J; Gan, H; Cebon, J;
Details: Publication Year 2026-09,Volume 48,Issue #9,Page 841-846
Journal Title: Clinical Therapeutics
Publication Type: Protocol
Abstract: PURPOSE: Medicinal cannabis is increasingly used in cancer care despite limited high-quality evidence to inform practice. It is increasingly legalized around the world; however, this has outpaced high-quality research on cancer symptom outcomes, leading to patient and prescriber uncertainty. This trial evaluates the safety profile, tolerability, and impact of medicinal cannabis on quality of life in advanced cancer. METHODS: This is a Phase I/II multicenter clinical trial. The Phase I component is open-label and aims to determine the safety profile and tolerability of medicinal cannabis use by evaluating clinical outcomes and pharmacokinetic profile. The Phase II component is a double-blind, randomized clinical trial that aims to determine the impact of medicinal cannabis on quality of life and symptom control (pain, anorexia, anxiety, sleep, nausea, treatment satisfaction, toxicity, and caregiver burden) using validated instruments in people with advanced cancer. FINDINGS & IMPLICATIONS: This trial is expected to generate important knowledge about the tolerability, efficacy, and adverse effects of medicinal cannabis in people with advanced cancer, with a particular focus on quality of life and symptom burden. Protocol adaptations aimed at enhancing inclusivity may be worth noting in future studies. Collectively, the findings have the potential to inform clinical practice, reduce decisional uncertainty among prescribers and patients, and affect care for the estimated 10 million people who die of advanced cancer annually worldwide. Australian New Zealand Clinical Trials Registry identifier: ACTRN12619001534178.
Publisher: Elsevier
Keywords: Humans; *Quality of Life; Double-Blind Method; *Neoplasms/drug therapy/psychology; *Medical Marijuana/adverse effects/therapeutic use/administration &; dosage/pharmacokinetics; Clinical Trials, Phase II as Topic; Clinical Trials, Phase I as Topic; Advanced cancer; Cannabis; Palliative care; Quality of life
Department(s): Palliative Care
Publisher's Version: https://doi.org/10.1016/j.clinthera.2026.06.018
Open Access at Publisher's Site: https://doi.org/10.1016/j.clinthera.2026.06.018
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2026-08-13 12:12:36

Last Modified: 2026-09-16 04:38:39