Medicinal CANnabis (CBD/THC) to prevent the symptoms and side effects of chemotherapy in people with advanced CANcer (CANCAN): protocol for a phase II, randomised, double-blind, placebo-controlled trial

Introduction

Chemotherapy can cause serious side effects, especially damage to the digestive system, known as gastrointestinal mucositis (GI-M). This can lead to problems like diarrhea, weight loss, pain, fatigue, and sleep issues. Managing these symptoms often requires multiple medications, which can be risky. The CANCAN trial explores how medicinal cannabis might help reduce these side effects.

About the CANCAN Trial

The CANCAN trial is a phase II study taking place at four hospitals in Australia. It involves 176 adults with certain types of cancer who will receive chemotherapy that can harm the digestive system. Participants will be randomly assigned to receive either medicinal cannabis or a placebo, both in the form of sublingual wafers.

The active cannabis product includes cannabidiol (CBD) and THC, the components believed to help manage symptoms. The main goal is to measure the impact on GI-M using a specific questionnaire, while secondary goals include assessing overall symptom burden, quality of life, and healthcare costs.

Patient-Centered Approach

The trial focuses on what patients experience by using measures reported directly by them. The aim is to provide medicinal cannabis during chemotherapy to prevent the symptoms related to mucositis.

Ethics and Communication

The study has received ethical approval, and all participants will give informed consent. Results will be shared in scientific journals and conferences to inform healthcare practices.

Opportunities for Clinics and Patients

Based on the trial data, clinics can:

  • Define clear goals for using medicinal cannabis to manage chemotherapy side effects.
  • Choose appropriate AI tools to support clinical needs.
  • Implement solutions step-by-step, starting with pilot projects to track results.

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