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Hematopoietic and Lymphatic System NeoplasmPhase 1/2NCT07658677

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

A Phase 1/2 study testing Actigraphy, Best Practice and Biospecimen Collection in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Theodore Brasky PhD at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Actigraphy, Best Practice and Biospecimen Collection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
15 Jan 2027to 31 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

1-800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Theodore Brasky, PhD, 614-293-3772, Theodore.Brasky@osumc.edu

    Theodore Brasky, PhD

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Actigraphy, Best Practice, Biospecimen Collection, Ecological Momentary Assessment, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ActigraphyOther

    Ancillary studies

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive usual care

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Ecological Momentary AssessmentOther

    Also called EMA

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Single Agent TherapyDrug

    Also called Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug Therapy

    Given cannabis gummy PO

Study groups in NCT07658677
Study groupRoleWhat they receive
Arm I (cannabis gummy)ExperimentalPatients receive a nightly dose of a cannabis-based gummy for 30 days on study. Patients also undergo blood sample collection on study.
Receives: Other: Actigraphy; Procedure: Biospecimen Collection; Other: Ecological Momentary Assessment; Other: Questionnaire Administration; Drug: Single Agent Therapy
Arm II (usual care)Active comparatorPatients receive usual care on study. Patients also undergo blood sample collection on study.
Receives: Other: Actigraphy; Other: Best Practice; Procedure: Biospecimen Collection; Other: Ecological Momentary Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to day 31

  2. 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.

    Measured: Up to day 31

  3. Proportion of participants who complete all study assessments

    Logistic regression will be used to identify factors associated with retention.

    Measured: Up to day 38

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start15 Jan 2027 (estimated)
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07658677
Sponsor's protocol ID
OSU-25388
Other IDs
NCI-2026-04099
Status last verified
Oct 2026
First submitted
16 Jun 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Actigraphy, Best Practice and Biospecimen Collection in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Theodore Brasky PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State University Comprehensive Cancer Center (1-800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AE) (time frame: Up to day 31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07658677.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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