1399TiP - Phase III, double-blind study of cannabis sativa extract in pain management and quality of life in patients with metastatic lung cancer: Protocol of a study (IPElife trial)

Background

Pain is one of the most common and problematic symptoms reported by cancer patients. The management of pain in these patients often requires multidisciplinary interventions and specialized palliative care. In this complex scenario, cannabis sativa extract has been identified as a possible adjunct therapy for symptom control in oncologic pain and improvement quality of life. Thus, given the limited treatment options available and high symptom burden faced by late-stage lung cancer patients, alternative therapies such as cannabis sativa extract offer a valuable addition to conventional pain management approaches.

Trial design

This is a randomized, prospective, double-blind, placebo-controlled, phase III protocol to compare the effects of cannabidiol on pain control and quality of life in patients with locally advanced or metastatic lung cancer. The study includes patients age ≥ 18 years with locally advanced or metastatic lung cancer confirmed by histopathology; ECOG performance status of 0, 1, or 2. Sample size calculation considered Cohen's effect size of 0.40, test power of 0.80, and a significance level of 5% (p-value < 0.05), it was estimated that the sample will total 32 participants, subdivided into two groups of 16 patients each. Thus, with an equal allocation ratio of 1:1. The Control Group (CG) will receive the standard care already adopted by the service (oral opioids), associated with placebo. The Experimental Group (EG) will guarantee the same care as the previously mentioned group (oral opioids), in addition to using CBD. The CBD administration protocol followed dose escalation, according to consensus recommendations, in which starts the CBD dose of 10 mg/day and titrates the dose every 5 days until the patient achieves their goals, or up to 100 mg/day. Each patient will remain in the study for about 5 months. The primary outcome includes pain control using the Visual Analog Scale (VAS) for pain. The secondary outcomes will be quality of life assessed by EORTC QLQ-C30 together with its specific module for lung cancer (QLQ-LC13). To assess medication adherence, the Medication Adherence Questionnaire (MAQ) version. The event adverse was assess with CTCAE.

Clinical trial identification

CAAE: 68929923.2.0000.5293, Ethics Committee number: 6.036.463.

Editorial acknowledgement

Legal entity responsible for the study

Liga Norte Riograndense Contra o Câncer.

Funding

Greencare Pharma.

Disclosure

D.D.A. Matias: Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo. All other authors have declared no conflicts of interest.