Cannabidiol
Name: Cannabidiol, 100 mg/ml Dosage: 2 ml three times a day (=600 mg CBD/day) Administration form: oil (oral)
CBDLoading study record…
Loading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-08-07
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Name: Cannabidiol, 100 mg/ml Dosage: 2 ml three times a day (=600 mg CBD/day) Administration form: oil (oral)
CBDName: Placebo Dosage: 2 ml three times a day (=0 mg CBD/day) Administration form: oil (oral)
Eligibility
primary outcomes
Time frame: Baseline and 9 weeks
Difference in average total daily dose of opioids (morphine milligram equivalents) between study participants receiving CBD and placebo.
secondary outcomes
Time frame: Baseline and 9 weeks
Difference in average worst pain intensity on numeric rating scale (NRS) between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
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 weeks
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 weeks
Difference in use of concomitant therapy (e.g., radiation, corticosteroids) between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Difference in quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 (EORTC-QLQ-C30) including global health status/quality of life (two items), functional scale (five items) and symptom scale (nine items). The scales range in score from 0 to 100. A high score for the global health status/quality of life represents a high quality of life. A high score for a functional scale represents a high level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Time frame: Baseline and 9 weeks
Difference in quality of life by European Organization for Research and Treatment of Cancer Quality of Life Prostate Cancer (EORTC-QLQ-PR25) including functional scale (two items) and symptom scale (four items). The scales range in score from 0 to 100. A high score for a functional scale represents a high level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Time frame: Baseline and 9 weeks
Difference in physical activity by average daily steps between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Difference in tumour activity by average serum prostate-specific antigen (PSA) and alkaline phosphatase (ALP) levels between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Difference in inflammation by average serum c-reactive protein (CRP), plasma cytokines and plasma soluble urokinase plasminogen activator receptor (suPAR) between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Difference in safety profile outcomes by laboratory testing of routine blood samples and Common Terminology Criteria for Adverse Events (CTCAE 5.0) between participants receiving CBD and placebo.
Publications
No exact PMID-linked public article is currently readable locally.