NCT06266611 - Cannabis for Palliative Care in Cancer | Crick

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to provide informed consent 2. Aged ≥25 years at Visit 1 (Baseline) 3. Have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months 4. Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety) 5. Desire to use cannabis to treat their symptoms 6. Must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months 7. Willing to practice acceptable methods of birth control until completing study medication Exclusion Criteria: 1. Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days 2. Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine) 3. Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide) 4. Current use of anti-psychotic medications 5. Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone) 6. Liver function tests (Alanine transaminase \[ALT\] and Aspartate transaminase \[AST\]) levels ≥2x the upper normal limits 7. Moderate or severe liver disease 8. Past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia 9. History of seizures 10. For female participant of childbearing potential: Pregnant or lactating at the time of study enrollment or trying to become pregnant. Lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum FSH level within the laboratory's reference range for postmenopausal females OR documented bilateral oophorectomy and/or hysterectomy 11. Physician response to passive consent indicating contraindications for participation. 12. Unwilling to refrain from cannabis use other than study drug for the entire study duration 13. Men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day

Outcomes

Primary Outcomes

Pain Interference

PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference. Total scores are between 8 and 40, with higher scores meaning more pain interference.

Time frame: Baseline, 4 weeks, 8 weeks

Pain Intensity

PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (7-day). Scores are between 0-10, with 0 being no pain and 10 being the worst imaginable pain.

Time frame: Baseline, 4 weeks, 8 weeks

Pain Inventory

Brief Pain Inventory (BPI) survey. Measures pain levels, pain interference, and relief from medication, and includes diagrams for labeling pain. For pain levels, various questions ask participants to rate pain on a scale of 0-10, 0 being no pain and 10 being pain as bad as you can imagine. For questions about pain interference, each question is on a scale of 0-10, where 0 does not interfere and 10 completely interferes. BPI is scored as an average of each subsection, where a higher average suggests greater severity of pain/more interference.

Time frame: Baseline, 4 weeks, 8 weeks

Sleep Disturbance

PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 4a. Scores are separated between the first question (sleep quality) and the remaining 7 questions. For the first question, scores are between 1 and 5, with 1 being very poor sleep quality and 5 being very good sleep quality. The remaining 7 questions are scored individually on a scale of 1--5; for some questions, higher scores mean less disturbance, and for others, a higher score means more disturbance.

Time frame: Baseline, 4 weeks, 8 weeks

Sleep-Related Impairment

PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep-Related Impairment 4a. Scores are between 4 and 20, with higher scores indicating more sleep-related impairment

Time frame: Baseline, 4 weeks, 8 weeks

Depression/Anxiety

Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.

Time frame: Baseline, 4 weeks, 8 weeks

Fatigue

PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 4a. Scores range from 4-20, with higher scores indicating more fatigue.

Time frame: Baseline, 4 weeks, 8 weeks

Health Related Quality of Life

Health Related Quality of Life Short Form 12 (SF-12). Scores range from 0-100 with higher scores indicating better health.

Time frame: Baseline, 4 weeks, 8 weeks

FACT-Cog Cognitive Function

Functional Assessment of Cognitive Function - Cognitive (FACT-Cog). Scores are transformed such that scores range from 0-132 and higher scores indicate a better quality of life/cognitive function.

Time frame: Baseline, 4 weeks, 8 weeks

Stroop Task Test of Cognitive Function

Stroop Task

Time frame: Baseline, 4 weeks, 8 weeks

DSST Test of Cognitive Function

Digit Symbol Substitution Task (DSST)

Time frame: Baseline, 4 weeks, 8 weeks

Conners Test of Cognitive Function

Conners Continuous Performance Test - Version 3 (CPT-3)

Time frame: Baseline, 4 weeks, 8 weeks

Plasma Cannabinoids

Plasma cannabinoid levels in participants will be measured from biological samples.

Time frame: Baseline, 4 weeks, 8 weeks

PROMIS Pain Intensity (Right Now)

PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity (Right Now). Scores are between 0-10, with 0 being no pain and 10 being the worst imaginable pain.

Time frame: 4 weeks

Drug Effects

Drug Effects Questionnaire (DEQ). Six questions about drug effects with possible answers of "not at all", "somewhat", and "extremely", where higher scores indicate higher drug effects.

Time frame: 4 weeks

ARCI-Marijuana Scale

Addiction Research Center Inventory - Marijuana Scale (ARCI-M). 12 True or false questions where more "true" answers indicate higher drug effects.

Time frame: 4 weeks

Drug Effects - Mood

Profile of Mood States (POMS). Scores are between 28-140, with higher scores indicating higher drug effects.

Time frame: 4 weeks

Drug Effects - Blood Cannabinoids

Acute plasma cannabinoid levels in participants will be measured from blood samples pre-drug administration, on-hour post drug administration, and 2-hours post drug administration at week 4 appointment.

Time frame: 4 weeks

Secondary Outcomes

Polypharmacy for Pain

Use of pain medications

Time frame: Baseline, 4 weeks, 8 weeks

Polypharmacy for Psychiatric Rx

Use of psychiatric medications

Time frame: Baseline, 4 weeks, 8 weeks

Polypharmacy for Sleep

Use of sleep medications

Time frame: Baseline, 4 weeks, 8 weeks

Cannabis for Palliative Care in Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts