Cannabidiol for Pain Relief of Patients With End-stage mCRPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorRegionshospital Nordjylland
About this trial
The goal of this clinical trial is to evaluate the effects of cannabidiol in patients with end-stage metastatic castration-resistant prostate cancer (mCRPC).
The primary objective is to determine whether cannabidiol (CBD) treatment can reduce the need for opioids in patients with end-stage mCRPC.
Additionally, the study will assess a range of clinical endpoints in patients with end-stage mCRPC, including:
1. The efficacy of CBD treatment in alleviating pain 2. The efficacy of CBD treatment in reducing the need for non-opioid medications and concomitant therapies 3. The impact of CBD treatment on physical activity and quality of life 4. The anti-inflammatory and potential anti-tumor properties of CBD 5. The safety of CBD treatment
Patients from Department of Urology, Aalborg University Hospital will be included. Participants will be treated with either CBD (200 mg) or placebo (0 mg) three times daily for nine weeks. At baseline, halfway and end of trial, participants will use an activity tracker and complete questionnaires regarding pain and quality of life and provide blood samples to measure inflammation and tumor activity. Also, they will complete a daily dairy regarding the study drug and intake of pain medication. Adverse events will be assessed by Common Terminology Criteria for Adverse Events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with mCRPC as documented by increasing PSA despite optimally attempted treatment, and no other therapeutic options.
Treatment-resistance or ineligible to standardized cancer therapy, incl. medical and surgical castration, chemotherapy, and super hormone treatment.
Minimum 3 months since radiation therapy, if part of treatment.
Opioid-requiring pain
Disqualifiers
Perception of worst pain <4.0 on the NRS within the last week prior to baseline visit70. (Inclusion if: three days with highest pain intensity have an average of ≥4.0 and/or three days where pain intensity is at least 4.0).
Pattern of short duration of response to all previous treatment regimens (<6 months) clinically assessed by the investigator.
Eastern Cooperative Oncology Group (ECOG) performance status >3 (scale 0-5).
Change in regular use of conventional pain medication within two weeks prior to baseline visit.
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabidiol
DrugName: Cannabidiol, 100 mg/ml Dosage: 2 ml three times a day (=600 mg CBD/day) Administration form: oil (oral)
Placebo
DrugName: Placebo Dosage: 2 ml three times a day (=0 mg CBD/day) Administration form: oil (oral)
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: CBDExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total daily dose of opioids (morphine milligram equivalents)
Difference in average total daily dose of opioids (morphine milligram equivalents) between study participants receiving CBD and placebo.
Time frame
Baseline and 9 weeksSecondary outcomes
1
Worst pain intensity on numeric rating scale (NRS)
Difference in average worst pain intensity on numeric rating scale (NRS) between participants receiving CBD and placebo.
Time frame
Baseline and 9 weeks2
Interference of pain on daily functioning
Difference in interference of pain on daily functioning by Brief Pain Inventory Short Form (BPI-SF) Interference Items between participants receiving CBD and placebo.
Time frame
Baseline and 9 weeks3
Total daily dose of non-opioid analgesics
Differnece in average total daily dose of non-opioid analgesics (e.g., NSAID, paracetamol, secondary analgesics) between participants receiving CBD and placebo.
Time frame
Baseline and 9 weeks4
Use of concomitant therapy
Difference in use of concomitant therapy (e.g., radiation, corticosteroids) between participants receiving CBD and placebo.
Time frame
Baseline and 9 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Regionshospital Nordjylland
Lead sponsor
Aalborg University Hospital
Collaborator
Source ClinicalTrials.gov