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

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.

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