Phase 2 Study on Cannabidiol CBD for Pain Relief in Men With End-stage Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the effects of cannabidiol CBD in patients with end-stage metastatic castration-resistant prostate cancer mCRPC. The study aims to determine if CBD treatment can reduce the need for opioids in managing pain for these patients. It also assesses CBDs impact on pain relief, the use of non-opioid medications, physical activity, quality of life, anti-inflammatory and potential anti-tumor effects, as well as its safety. Participants will receive either CBD oil 200 mg per dose, three times daily for a total of 600 mg per day or a placebo oil with no CBD, over a nine-week period. The study uses a randomized, double-blinded, placebo-controlled design to compare these two groups. At baseline, halfway, and at the end of the trial, participants will use an activity tracker, complete questionnaires about pain and quality of life, and provide blood samples to evaluate inflammation and tumor activity. They will also keep a daily diary of their study drug intake and pain medication use. Throughout the study, adverse events will be monitored using standard criteria. Researchers will measure total daily opioid use as the primary outcome and assess various secondary outcomes including pain intensity, pain interference with daily functioning, use of non-opioid analgesics, quality of life, physical activity, tumor activity, inflammation, and safety. Participation lasts nine weeks with assessments at three key time points and continuous daily recording of medication use.

Cannabidiol for Pain Relief of Patients With End-stage mCRPC