NCT04042545.

Study name	Safety and efficacy of inhaled cannabis for the uncontrolled pain relief in patients with advanced cancer (PLENITUDE)
Methods	Phase 2 Allocation: randomised Primary purpose: treatment Blinding: participant, care provider, investigator, outcomes assessor Assignment: parallel
Participants	78 participants with uncontrolled cancer pain relief
Interventions	1 cannabis dosing capsule inhaled 3 times a day with a vaporiser device vs 1 placebo dosing capsule inhaled 3 times a day with a vaporiser device
Outcomes	Primary outcome Uncontrolled cancer pain measured using a patient self‐administered questionnaire (change from baseline in the EORTC‐QLQ‐C15‐PAL pain multi‐item scale score at week 4). EORTC‐QLQ‐C15‐PAL items rated on a scale of 1 (not at all) to 4 (very much). High scores on a symptom scale correlate to increased symptom burden Secondary outcome Overall health‐related quality of life of participants with uncontrolled symptoms related to advanced cancer measured using the self‐rating EORTC‐QLQ‐C15‐PAL (change from baseline to week 4). EORTC‐QLQ‐C15‐PAL single‐item scale is rated from 1 (very poor) to 7(excellent). High scores on a functional scale correspond to better functioning Physical, emotional and total symptom distress measured using self‐administered ESAS‐r‐CS (change from baseline to weeks 1 and 4): 11 core symptoms: pain, tiredness, nausea, depression, anxious, drowsiness, appetite, feeling of well‐being, shortness of breath, constipation and trouble sleeping. 11‐point scale ranging from 0 (no symptom) to 10 (worst possible). Palliative Performance Scale version 2 scored by a healthcare professional for measuring functional status in people at end of life (change from baseline to weeks 1 and 4). Scores each dimension from 100% to 0% (death), with 10% denoting the lowest level of functioning. Satisfaction of family caregivers of people with advanced cancer measured using a caregiver‐administered questionnaire (change from baseline to weeks 1 and 4). Scale range is a left to right on a 7‐item scale for caregiver. Each item is scored from 5 (much more satisfied now) to 1 (much less satisfied now). Distress of people with advanced cancer measured using a patient‐administered questionnaire (change from baseline to week 4). Distress thermometer adopted as a screening measure to identify and address psychological distress in people with cancer. Results support a cut‐off score of 3 on the distress thermometer to indicate people with clinically elevated levels of distress
Starting date	30 July 2020
Contact information	Contact: Suzanne Sisley, MD Scottsdale Research Institute Address: Cave Creek, Arizona, 85331, USA
Notes	Sponsors and collaborators: Tetra Bio‐Pharma

BPI: Brief Pain Inventory; CBD: cannabidiol; CR: controlled release; CTCAE: Common Terminology Criteria for Adverse Events; delta 9‐THC: delta 9‐tetrahydrocannabinol; DASS‐21: 21‐item Depression, Anxiety and Stress Scale; EORTC‐QLQ‐C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires – Cancer; EORTC QLQ PAL‐Q30/EORTC‐QLQ‐C15‐PAL: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Palliative; ESAS TSDS: Edmonton Symptom Assessment System Total Symptom Distress Score; ESAS‐r‐CS: Revised Edmonton Symptom Assessment System – Core Symptoms; NPRS: Numeric Pain Rating Scale; NRS: Numeric Rating Scale; OME: oral morphine equivalent; UKU: Udvalg for Kliniske Undersøgelser.