Piloting cannabis for sleep disturbance in palliative care over 5 weeks: The pillow study protocol

Background Sleep disturbance affects 60% of cancer patients, 3-fold that of the general population, and is frequently driven by clinical characteristics, physical symptoms, and psychological distress. Sleep disturbance and other symptoms often exacerbate one another, leading to reduced health-related quality of life (HRQOL). Sleep is the most commonly reported reason for cannabis use among adults with cancer, yet clinical evidence supporting its use for symptom management remains limited. Objectives This report describes a protocol for a pilot randomized trial designed to evaluate the safety and feasibility of a cannabis-based intervention and to explore its preliminary efficacy for sleep disturbance and HRQOL. Methods This pilot parallel-arm randomized clinical trial will enroll 50 patients from the Ohio State University Comprehensive Cancer Center (OSUCCC; anticipated Fall 2026). Eligible participants will be new to the OSUCCC’s Palliative Care clinic and report at least moderate sleep disturbance. Participants will be randomized by sex and race strata to receive either usual care or a nightly oral cannabis gummy containing 5 mg Δ-9-tetrahydrocannabinol (THC) and 5 mg cannabidiol (CBD), taken 1 hour before bedtime for 30 days. Adverse events will be monitored throughout the study. Sleep, HRQOL, and related symptoms will be assessed using self-reported questionnaires, ecological momentary assessments, and actigraphy. Conclusions Findings will provide critical safety, feasibility, and preliminary efficacy data to support a future large-scale, multisite trial targeting sleep disturbance and symptom palliation in cancer care.