Skip to main content

Table 1 MedCan study details

From: Using a qualitative sub-study to inform the design and delivery of randomised controlled trials on medicinal cannabis for symptom relief in patients with advanced cancer

 

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