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

Piloting a Novel Therapeutic for Sleep Disturbance in Palliative Care Over 5 Weeks: The PILLOW Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Procedure: Biospecimen Collection; Other: Actigraphy; Other: Ecological Momentary Assessment; Drug: Single Agent Therapy

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the safety and feasibility of a nightly cannabis gummy versus usual care among palliative care patients at the Ohio State University Comprehensive Cancer Center (OSUCCC).

SECONDARY/EXPLORATORY OBJECTIVE:

I. To examine the preliminary efficacy of a nightly cannabis gummy versus usual care on sleep disturbance and HRQOL among palliative care patients at the OSUCCC.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive a nightly dose of a cannabis-based gummy for 30 days on study. Patients also undergo blood sample collection on study.

ARM II: Patients receive usual care on study. Patients also undergo blood sample collection on study.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 1-800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
      • Contact: Theodore Brasky, PhD; Phone Number: 614-293-3772; Email: Theodore.Brasky@osumc.edu
      • Principal Investigator: Theodore Brasky, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 current cancer regimen)

  • AST: < 3X institutional upper limit of normal (10-39 U/L)
  • ALT: < 3X institutional upper limit of normal (10-52 U/L)
• Glomerular filtration rate (GFR): ≥ 30 mL/min/1.73 m^2 using Cockcroft-Gault (within the past 3 months or predating their current cancer regimen)
• Normal electrocardiogram (EKG); or non-normal EKG with no significant arrhythmias or severe congestive heart failure (CHF). A normal EKG defined as sinus rhythm with no ST or T wave changes any clinically concerning EKGs will be reviewed by the study physician to determine participant eligibility into the study (within the past 3 months or predating their current cancer regimen)
• Patients are allowed to take any type of analgesic pain medication at baseline, but must be on a stable dose of pain medication for two weeks and not requiring rapid dose escalation
• Individuals able to become pregnant will agree to practice a highly effective form of birth control. Contraception including oral birth control pills, intrauterine device (IUD), condoms, abstinence must be used alone or in combination for the duration of enrollment

• Agree to study requirements, as described in the consent form:

  • No driving, use of heavy machinery, or caring for children for 12 hours (hrs) after dose
  • Wearing fitness tracker 24/7 for the duration of the study and are able to charge the device once per week.
  • No cannabis (i.e., outside of provided study drug), or illegal drug use (e.g., methamphetamine, non-prescription opioids or fentanyl)
  • Calls so that study staff can monitor dosing
  • Completing weekly ecological momentary assessment (EMA) questionnaires

Exclusion Criteria:

• History of hypersensitivity to cannabis, THC, or CBD
• Current, regular use of cannabis/marijuana, THC-containing prescription medications (dronabinol/Marinol/Syndros, nabilone/Cesamet), prescription CBD (Epidiolex), or over-the-counter CBD oil within the past 6 months
• Concurrent use of medications that are contraindicated with medical cannabis: valproate, clobazam, warfarin, fluoxetine, disulfiram, tamoxifen, Ibrance, Gleevec, amphetamines, buprenorphine, methadone, alprazolam, amiodarone, fluconazole, ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin. The study physician will review eligibility for participants taking medications that are moderate to strong inhibitors and inducers of enzymes CYP3A4 (epidiolex, marinol), CYP2C19 (epidiolex), and CYP2C9 (marinol)
• The following medications if being used to treat sleep: benzodiazepines or nonbenzodiazepine medications, antidepressants, antihistamines, supplements (e.g., melatonin)
• Cardiac conditions contraindicated for cannabis use, moderate/severe or unstable CHF, symptomatic valvular heart disease, and uncontrolled arrhythmias as reviewed by the study team physician. Investigators will consult with a cardio-oncologist if needed
• Abnormal screening ECG with corrected QT (QTc) intervals of ≥ 450 (males) and ≥ 460 (females), as reviewed by the study physician
• Baseline orthostatic hypotension drop of blood pressure (BP) ≥ 20 mmHg, or in diastolic BP of ≥ 10mmHg or experience of lightheadedness or dizziness during the test
• Based on a measurement at baseline, we will exclude participants with current hypertension defined as BP > 165/100, abnormal ECG results or a resting heart rate defined as > 110bpm
• Concomitant use of checkpoint inhibitors (e.g., anti-PD1, PDL1, CTLA4)
• Current use of investigational agents or < 3 months after the use of investigational agents
• Diagnosis of sleep apnea
• Allergy to any constituent/ingredient contained in the edible doses
• Psychiatric illness/social situations that would limit adherence with study requirements (e.g., bipolar disorder, psychosis). Mild/moderate mood disorders treated by medications that are not expected to increase cannabis-induced sedation/impairment are acceptable with physician approval
• Any known or suspected history or family history of schizophrenia, bipolar disorder, or other psychotic illness
• Pregnant or breastfeeding
• Sole caretaker of minor children living in the household
• History of seizure disorder, epilepsy (controlled or uncontrolled)
• Current legal obligations (parole, probation, incarceration)
• Current substance use disorder (including cannabis use disorder), or currently enrolled in substance use treatment
• Self-reported cannabis and synthetic cannabinoid use in the past 6 months (medical or non-medical use is exclusionary)
• Self-reported illicit drug use in past 60 days (ex: methamphetamine, heroin, illicit fentanyl) or self-reported daily alcohol use
• No access to internet/data or devices needed to participate in video calls (day 14) and EMA assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (cannabis gummy); Patients receive a nightly dose of a cannabis-based gummy for 30 days on study. Patients also undergo blood sample collection on study.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection; Other: Actigraphy; Ancillary studies; Other: Ecological Momentary Assessment; Ancillary studies; Other Names: EMA; Drug: Single Agent Therapy; Given cannabis gummy PO; Other Names: Monotherapy; Drug Monotherapy; Single Agent Treatment; Single Drug Therapy
Active Comparator: Arm II (usual care); Patients receive usual care on study. Patients also undergo blood sample collection on study.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection; Other: Actigraphy; Ancillary studies; Other: Ecological Momentary Assessment; Ancillary studies; Other Names: EMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AE)	Will be evaluated by assessing the frequency, grade, and type of AE reported by participants. The frequency and percentage of participants experiencing each grade of AE will be reported for both groups.	Up to day 31
Proportion of participants who adhere to the study protocol	Includes consistent use of actigraphy, completion of self-reported measures, and measurement of self-reported cross-over events. Adherence rates will be analyzed using descriptive statistics. Logistic regression will be used to identify factors associated with adherence.	Up to day 31
Proportion of participants who complete all study assessments	Logistic regression will be used to identify factors associated with retention.	Up to day 38

Collaborators and Investigators

• Sponsor: Theodore Brasky PhD
• Investigators: Principal Investigator: Theodore Brasky, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Quality of Health Care; Quality Indicators, Health Care; Behavioral Disciplines and Activities; Psychological Tests; Guidelines as Topic; Quality Assurance, Health Care; Monitoring, Physiologic; Accelerometry; Standard of Care; Specimen Handling; Drug Therapy; Practice Guidelines as Topic; Ecological Momentary Assessment; Actigraphy
• Other Study ID Numbers: OSU-25388; NCI-2026-04099 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No