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

NCT07658677 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-25388NCI-2026-04099
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Arm I (cannabis gummy)

EXPERIMENTAL

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

Other: Actigraphy; Procedure: Biospecimen Collection; Other: Ecological Momentary Assessment; Other: Questionnaire Administration; Drug: Single Agent Therapy

Arm II (usual care)

ACTIVE COMPARATOR

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

Other: Actigraphy; Other: Best Practice; Procedure: Biospecimen Collection; Other: Ecological Momentary Assessment; Other: Questionnaire Administration

Interventions

Actigraphy OTHER

Ancillary studies

Arm I (cannabis gummy); Arm II (usual care)

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm II (usual care)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Arm I (cannabis gummy); Arm II (usual care)

Ecological Momentary Assessment OTHER

Ancillary studies

Also known as: EMA

Arm I (cannabis gummy); Arm II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (cannabis gummy); Arm II (usual care)

Single Agent Therapy DRUG

Given cannabis gummy PO

Also known as: Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug Therapy

Arm I (cannabis gummy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theodore Brasky PhD: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Actigraphy; Practice Guidelines as Topic; Standard of Care; Specimen Handling; Ecological Momentary Assessment; Drug Therapy

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Psychological Tests; Behavioral Disciplines and Activities; Therapeutics

Study Officials

• Theodore Brasky, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (1)