Not Yet RecruitingPhase 1/2

Cannabis Gummy for the Improvement of Sleep and Quality of Life in Patients With Cancer, Pillow Trial

United States50 participantsStarted 2026-09-01

Plain-language summary

This clinical trial tests how well a cannabis gummy works in improving sleep and quality of life in patients with cancer. Many people with cancer (about 60%) have trouble sleeping, which can lower their quality of life. Sleep disturbance is defined as difficulty initiating or maintaining sleep, waking up earlier than desired and being unable to fall back to sleep, and excessive daytime sleepiness. In adults with cancer, sleep disturbance may be caused by multiple, often co-occurring factors including diagnosis, type, and stage of cancer, treatment regimen, physical complaints (e.g., pain), and psychological distress. Some patients use cannabis to help with sleep, but its effects are not well understood. Cannabis, which some people call marijuana, refers to the dried leaves, flowers, stems, and seeds of the cannabis sativa L plant. The plant contains at least 125 different cannabinoids, including delta-9 tetrahydrocannabinol (THC). Delta-9 THC is the most abundant form of THC in the cannabis plant. It has intoxicating effects, meaning it can temporarily alter a person's mood, thoughts, and perceptions (a "high"). This study will help researchers learn how cannabis affects sleep and quality of life compared to usual care.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * New patients in the OSUCCC's Palliative Care clinics who have histologically or cytologically confirmed malignancy of any anatomic site. This applies to either newly diagnosed cancer or those with preexisting malignancy receiving treatment * Reported sleep disturbance (≥ 4) in the Edmonton Symptom Assessment System, the clinic's symptom screener administered at every visit * Patients with active cancers and are under any line of treatment or have received cancer treatment in the past 6 months (please see notable exceptions in the exclusion criteria - patients taking checkpoint inhibitors and investigational agents will not be eligible) * If patients are currently receiving cancer therapy, they must have been taking their current anti-cancer intervention/ therapy regimen for at least one month prior to enrollment (to ensure no safety or toxicity issues with study drug initiation) * Age ≥ 18 years * English speaking with the ability to understand and the willingness to sign a written informed consent document * Eastern Cooperative Oncology Group performance status ≤ 3 * Total bilirubin: \< 3X institutional upper limit of normal (1.5 mg/dl) (within the past 3 months or predating their current cancer regimen) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): \< 3X institutional upper limit of normal (within the past 3 months or predating their …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events (AE)

Timeframe: Up to day 31

Proportion of participants who adhere to the study protocol

Timeframe: Up to day 31

Proportion of participants who complete all study assessments

Timeframe: Up to day 38

Trial details

NCT IDNCT07658677

SponsorTheodore Brasky PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

The Ohio State University Comprehensive Cancer Center

1-800-293-5066 OSUCCCClinicaltrials@osumc.edu

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