Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
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.
Interventions
OTHERActigraphy
Ancillary studies
OTHERBest Practice
Receive usual care
PROCEDUREBiospecimen Collection
Undergo blood sample collection
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Given cannabis gummy PO
Sponsors
Theodore Brasky PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AE) | Up to day 31 | 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. |
| Proportion of participants who adhere to the study protocol | Up to day 31 | 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. |
| Proportion of participants who complete all study assessments | Up to day 38 | Logistic regression will be used to identify factors associated with retention. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORTheodore Brasky, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed