Cannabis for Palliative Care in Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Colorado, Boulder
About this trial
Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide informed consent
Aged ≥25 years at Visit 1 (Baseline)
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
Currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety)
Disqualifiers
Report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days
Current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine)
Current use of medications known to have major interactions with Epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide)
Current use of anti-psychotic medications
Trial design
Design model
Parallel
Treatments tested in this trial
fsCBD Cannabidiol
DrugFull Spectrum hemp-derived CBD (fsCBD; 200mg CBD/4mg THC) capsules produced by Ecofibre/Ananda Hemp will be used
Placebo
DrugPlacebo arm; capsules produced by Ecofibre/Ananda Hemp will be used
bsCBD Cannabidiol
DrugBroad spectrum hemp-derived CBD (bsCBD; 200mg CBD) capsules produced by Ecofibre/Ananda Hemp will be used
Treatment groups
185 Participants
are divided into 3 treatment groupsGroup A: Full-Spectrum Hemp-Derived CBD (fsCBD)Experimental treatment 1 intervention
Group B: Broad-Spectrum Hemp-Derived CBD (bsCBD)Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSecondary outcomes
1
Polypharmacy for Pain
Use of pain medications
Time frame
Baseline, 4 weeks, 8 weeks2
Polypharmacy for Psychiatric Rx
Use of psychiatric medications
Time frame
Baseline, 4 weeks, 8 weeks3
Polypharmacy for Sleep
Use of sleep medications
Time frame
Baseline, 4 weeks, 8 weeksOther outcomes
1
Cancer Treatment Type
Type of treatment participant is using for cancer, including specific type of immunotherapy, if relevant and known
Time frame
Baseline2
Cancer Disease Progression
Assess cancer disease progression and report as outcome
Time frame
Baseline, 4 weeks, 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov