Insomnia, Malignant Solid Neoplasm
Conditions
Brief summary
This phase II trial compares THC versus (vs.) THC with CBD vs. placebo to improve sleep quality for patients with solid organ cancer and insomnia. Many patients who are diagnosed with cancer struggle with sleep disorders after receiving a diagnosis. Insomnia is the most reported sleep disturbance amongst cancer patients, often stemming from physical changes from tumor growth and surgery, side effects from supportive care and chemotherapy, and stress associated with the diagnosis. THC with or without CBD may improve insomnia symptoms and sleep quality.
Interventions
PROCEDUREBiospecimen Collection
Undergo blood sample collection
DRUGPlacebo Administration
Given placebo tincture sublingually
Given THC tincture sublingually
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 25 years * History of solid organ (not hematologic) cancer diagnosis (except patients with central nervous system \[CNS\] cancer who have history of seizures or untreated brain metastasis). Patients may be either in remission or have active disease. Patients must be considered medically fit by their treating physician to participate in the study * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * History of insomnia for which the patient would like an intervention * Insomnia Severity Index Score ≥ 15. Patients can answer questions orally rather than completing worksheet, for screening only * Willing to abstain from alcohol, anticholinergics, and benzodiazepines while on study * If on opioids, must be a stable dose ≥ 30 days prior to randomization (no changes to prescriptions, this can include as needed \[PRN\] dosing) with no plans to increase during the study period * White blood cell count (WBC) ≥ 3,000/mm\^3 (obtained ≤ 30 days prior to randomization) * Hemoglobin ≥ 8 g/dL (obtained ≤ 30 days prior to randomization) * Platelet count ≥ 50,000/mm\^3 (obtained ≤ 30 days prior to randomization) * Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) (obtained ≤ 30 days prior to randomization) * Glomerular filtration rate (GFR) \> 20 (obtained ≤ 30 days prior to randomization) * Total bilirubin ≤ 1.5 x ULN (obtained ≤ 30 days prior to randomization) * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only * Provide informed consent * Ability to complete questionnaires and diary by themselves or with assistance * Willingness to wear a home EEG monitor and have a blue-tooth device for recording (Smart phone, iPad) * Normal urine toxicology screen ≤ 7 days prior to randomization (abstinence from cannabinoids and other common drugs of abuse: cocaine, benzodiazepines, and methamphetamines)
Exclusion criteria
* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown: * Pregnant persons * Nursing persons * Persons of childbearing potential or are able to father a child who are unwilling to employ adequate contraception (e.g., hormonal methods, barrier methods, intrauterine device, abstinence) during the study and for 14 days after their last dose * Currently using any other pharmacologic agents, over the counter medications or supplements to specifically treat insomnia for ≤ 7 days prior to randomization * Known primary sleep disorder (restless leg syndrome \[RLS\], uncontrolled apnea, narcolepsy) * Cannabis use ≤ 30 days prior to randomization * Active cardiac disease (symptomatic congestive heart failure \[CHF\], arrhythmias, untreated coronary artery disease \[CAD\]) * On warfarin, topiramate, clobazam, or other high-risk CYP3A4 substrates (amiodarone, macrolides, verapamil, fluoxetine, clotrimazole, ketoconazole) per pharmacy review * History of Human Papilloma Virus positive (HPV+) head and neck cancer * Any concomitant medications that, in the judgment of the treating physician or pharmacist, could result in an adverse drug effect (increase in substrate level); pharmacy e-consult will be conducted for each patient to determine CYP interactions * Patients with a history of psychotic disorders (including but not limited to schizophrenia, major depression with psychotic features, brief psychotic disorder). Patients with depression, manic/depression, or obsessive compulsive disorder (OCD) will need clearance from their mental health provider that these medical conditions are controlled and that the patient is appropriate for the study * Any known hypersensitivity to cannabis * Patients with CNS cancer or brain metastasis who have had or have seizures * History of, or current substance use disorder * Patients with electrocardiography (ECG) test with corrected QT interval (QTc) ≥ 450 msec for men and ≥ 470 msec for women * Current or past suicidal ideation or suicidal behavior within the last year, as assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS) * Patients with history off falls in the past 6 months, or considered at risk for falling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Sleep Index score | From baseline to week 4 | The Insomnia Sleep Index (ISI) is a brief screening tool used to assess insomnia symptoms and sleep patterns over the past week. It consists of 7 questions answered on a scale of 0 (not al all) to 4 (not very much). Total scores range from 0-28 with higher scores indicating greater severity of clinical insomnia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Score | From baseline to 4 weeks | Assessed using the Linear Analog Scale Assessment (LASA) of Quality of Life (QOL) scale, which consists of a single question related to quality of life over the past week. The scale is answered on a scale of 0 (worst it can be) to 10 (best it can be). Total scores range from 0-10 with higher scores indicating greater quality of life. |
| Change in Daytime Sleepiness | From baseline to end of treatment (day 35) | As measured by the Patient-Reported Outcomes Measurement Information System Fatigue (PROMIS-Fatigue) Item Bank instrument. The PROMIS-Fatigue questionnaire, a subscale of the PROMIS-29, measures fatigue and related symptoms over the past seven days. It consists of four items rated on a scale of 1(not at all) to 5 (very much). Total scores range from 4-20 with higher scores indicating greater experience of fatigue. |
| Average amount of deep sleep | From baseline to week 4 | As measured by home electroencephalography (EEG). Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint. |
| Average amount of light REM sleep | From baseline to week 4 | As measured by home EEG. Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint. |
| Average time awake | From baseline to week 4 | As measured by home EEG. Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint. |
| Amount of sleep per day | From baseline to week 4 | As measured by home EEG. Will compare pair-wise between the three treatment arms. Will be compared using the same methodology as used for the primary endpoint. |
| Change in mood - PHQ-9 | From baseline to end of treatment (day 35) | The Patient Health Questionnaire 9-item (PHQ-9) scale is a self-report questionnaire used to assess severity of depression over the last 2 weeks. The PHQ-9 consists of nine items rated on a scale of 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with higher scores indicating greater severity of depression symptoms. |
| Change in mood - GAD-7 | From baseline to end of treatment (day 35) | The General Anxiety Disorder 7-item (GAD 7) scale is used to assess symptoms and feelings of anxiety over the past two weeks. The GAD-7 consists of 7 questions answered on a scale of 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21 with higher scores indicating more severe anxiety symptoms. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
CONTACTSusie Lewis-Peters, RN
PRINCIPAL_INVESTIGATORStacy D. D'Andre, MD
Mayo Clinic in Rochester
Outcome results
None listed