Efficacy and Safety of Cannabidiol for Pain Relief of Patients With End-stage Metastatic Castration Resistant Prostate Cancer - a Randomised Double-blinded Placebo-controlled Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Total daily dose of opioids (morphine milligram equivalents)
研究概览
简要总结
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:
- The efficacy of CBD treatment in alleviating pain
- The efficacy of CBD treatment in reducing the need for non-opioid medications and concomitant therapies
- The impact of CBD treatment on physical activity and quality of life
- The anti-inflammatory and potential anti-tumor properties of CBD
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Perception of worst pain <4.0 on the NRS within the last week prior to baseline visit
- •(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.
- •A history of substance use disorder.
- •Functional liver insufficiency with an alanine transaminase (ALT) >2X ULN and/or bilirubin >2X ULN assessed by a blood sample taken at screening.
- •Renal failure with an estimated glomerular filtration rate (eGFR) < 30mL/min/1,73m2 assessed by a blood sample taken at screening.
- •Known heart failure - New York Heart Association III - IV (scale I-IV)
- •Known severe chronic obstructive lung disease (Forced Expiratory Volume in the first second (FEV1) <50%)
- •Use of THC-containing cannabis products measured by a urine sample at screening.
- •Any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with compliance or the assessment of efficacy in this trial.
- •Hypersensitivity to the active substance
- •Not capable of giving informed consent.
- •Not capable of understanding, write or read Danish.
研究组 & 干预措施
CBD
干预措施: Cannabidiol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Total daily dose of opioids (morphine milligram equivalents)
时间窗: Baseline and 9 weeks
Difference in average total daily dose of opioids (morphine milligram equivalents) between study participants receiving CBD and placebo.
次要结局
- Worst pain intensity on numeric rating scale (NRS)(Baseline and 9 weeks)
- Interference of pain on daily functioning(Baseline and 9 weeks)
- Total daily dose of non-opioid analgesics(Baseline and 9 weeks)
- Use of concomitant therapy(Baseline and 9 weeks)
- Quality of life by EORTC-QLQ-C30(Baseline and 9 weeks)
- Quality of life by EORTC-QLQ-PR25(Baseline and 9 weeks)
- Physical activity(Baseline and 9 weeks)
- Tumour activity(Baseline and 9 weeks)
- Inflammation(Baseline and 9 weeks)
- Safety profile outcomes(Baseline and 9 weeks)