ACTRN12619001534178.

Study name	A phase I/II double‐blind, randomised controlled trial assessing effect of medicinal cannabis on quality of life and symptom control in advanced cancer
Methods	Phase 1/2 Purpose: treatment Allocation: randomised controlled trial Blinding: yes Assignment: parallel Type of endpoint: safety/efficacy
Participants	People with incurable advanced cancer, of any histological subtype; target sample size: 116
Interventions	CGL002 (medicinal cannabis) vs placebo CGL002 2.5–30 mg administered 1–3 times a day, oral liquid administered via syringe, daily for a maximum of 168 days/6 months.
Outcomes	Primary outcomes Phase 1 (composite) To determine the safety, tolerability and dose range of CGL002 by evaluating and characterising the pharmacokinetic profile of medicinal cannabis and active metabolites, analysis of dose‐limiting toxicities and adverse events. Pharmacokinetic parameters include serum concentration of CBD002 and metabolites. Dose‐limiting toxicities and adverse events measured by CTCAE criteria, which can be classified by clinical examination, laboratory findings or participant reported symptoms (baseline (predose), and 1, 2, 4, and 8 hours postadministration of study drug, on days 1, 8, 15 and 29 postinitiation of medicinal cannabis/placebo). Phase 2 To determine the impact of medicinal cannabis on global quality of life, as measured by change in EORTC QLQ PAL‐Q30 from baseline (day 29 postinitiation of medicinal cannabis/placebo). Secondary outcome Phase 1 To undertake exploratory pharmacokinetics studies profiling the medicinal cannabis and active metabolites. Pharmacokinetic parameters assessed include serum concentration of CBD002 and metabolites (day 29 postinitiation of medicinal cannabis or placebo) To test the feasibility of the objectives proposed in the Phase 2 study. This includes the impact of medicinal cannabis on global quality of life, pain, insomnia, nausea, anxiety and treatment satisfaction. Feasibility will be assessed by questionnaires understandable and acceptable to all participants, dosing uptitration schedule able to be followed by all participants and feasibility of self‐administration (day 29 postinitiation of medicinal cannabis or placebo) Phase 2 To evaluate impact of medicinal cannabis on (at days 56, 84, 112, 140 and 168 postinitiation of medicinal cannabis/placebo): anxiety (measured using Hospital Anxiety and Depression Scale) sleep (measured using Insomnia Severity Index), nausea (measured using NRS) pain (measured using change in Brief Pain Inventory – Short Form) anorexia (measured using Functional Assessment of Anorexia/Cachexia and weight) global quality of life (measured using EORTC QLQ PAL‐Q30) caregiver burden measured using Caregiver Quality of Life Index – Cancer treatment satisfaction measured using Treatment Satisfaction Questionnaire for Medication To determine the safety and optimal Phase 2 dose range of medicinal cannabis measured by occurrence of dose‐limiting toxicities and adverse events, clinically meaningful changes from baseline in clinical laboratory parameters using standard CTCAE criteria (composite outcome at days 56, 84, 112, 140 and 168 postinitiation of medicinal cannabis/placebo)
Starting date	25 September 2020
Contact information	Name: Dr Jodie Palmer Address: Olivia Newton‐John Cancer Research Institute Level 5, ONJWRC 145 Studley Road Heidelberg VIC 3084 Australia Telephone: +61 3 9496 3573 E‐mail: trials@onjcri.org.au
Notes	Funding: Victorian Cancer Agency