Cannabis for Palliative Care in Cancer
This study is looking at how different hemp-derived CBD (Cannabidiol) capsules affect symptoms in cancer patients. Researchers are comparing capsules with full-spectrum CBD (which includes 200mg CBD and 4mg THC), broad-spectrum CBD (200mg CBD without THC), and a placebo (an inactive capsule). You might be able to join if you are at least 25 years old, have a solid tumor, and are experiencing pain, sleep problems, or mood issues like depression or anxiety. The study aims to see if these CBD capsules can improve your pain, sleep, and mood. The current status of this study is unclear, and it plans to enroll 185 patients.
- Study design
- This interventional study will compare three different treatments (full-spectrum CBD, broad-spectrum CBD, or a placebo) in 185 cancer patients.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain interference, pain intensity, and pain inventory will be measured at the start of the study, and again at 4 weeks and 8 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Cannabis for Palliative Care in Cancer
At a glance
Conditions
NCT06266611
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Anschutz Health Sciences Building
Aurora, Coloradostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Pain InterferenceBaseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference. Total scores are between 8 and 40, with higher scores meaning more pain interference.
- Pain IntensityBaseline, 4 weeks, 8 weeks
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.
- Pain InventoryBaseline, 4 weeks, 8 weeks
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.
- Sleep DisturbanceBaseline, 4 weeks, 8 weeks
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.
- Sleep-Related ImpairmentBaseline, 4 weeks, 8 weeks
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
- Depression/AnxietyBaseline, 4 weeks, 8 weeks
Depression Anxiety Stress Scale - 21 Item (DASS-21). Scores are between 0 and 63, with higher scores indicating more negative emotional states.
- FatigueBaseline, 4 weeks, 8 weeks
PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 4a. Scores range from 4-20, with higher scores indicating more fatigue.
- Health Related Quality of LifeBaseline, 4 weeks, 8 weeks
Health Related Quality of Life Short Form 12 (SF-12). Scores range from 0-100 with higher scores indicating better health.
- FACT-Cog Cognitive FunctionBaseline, 4 weeks, 8 weeks
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.
- Stroop Task Test of Cognitive FunctionBaseline, 4 weeks, 8 weeks
Stroop Task
- DSST Test of Cognitive FunctionBaseline, 4 weeks, 8 weeks
Digit Symbol Substitution Task (DSST)
- Conners Test of Cognitive FunctionBaseline, 4 weeks, 8 weeks
Conners Continuous Performance Test - Version 3 (CPT-3)
- Plasma CannabinoidsBaseline, 4 weeks, 8 weeks
Plasma cannabinoid levels in participants will be measured from biological samples.
- PROMIS Pain Intensity (Right Now)4 weeks
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.
- Drug Effects4 weeks
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.
- ARCI-Marijuana Scale4 weeks
Addiction Research Center Inventory - Marijuana Scale (ARCI-M). 12 True or false questions where more "true" answers indicate higher drug effects.
- Drug Effects - Mood4 weeks
Profile of Mood States (POMS). Scores are between 28-140, with higher scores indicating higher drug effects.
- Drug Effects - Blood Cannabinoids4 weeks
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.