2024-513951-33-00招募中2 期
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 (ProCan)
Regionshospital Nordjylland1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年4月29日最近更新:
适应症
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
- 1
- 主要终点
- Difference in average total daily dose of opioids (morphine milligram equivalents) during the trial participation with particular focus on the last week prior to end of trial (EOT) comparatively between study participants receiving CBD and placebo, respectively
研究概览
简要总结
To assess efficacy of CBD treatment for decreased need of opioids in patients with end-stage metastatic castration resistant prostate cancer
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with mCRPC as documented by increasing prostate specific antigen 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 prostatectomy or radiation therapy
- •Perception of 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)
- •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
- •Not capable of giving informed consent
- •Not capable of understanding, write or read Danish
- •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 or higher (scale 0-5)
- •Change in use of conventional pain medication within two weeks prior to baseline visit
- •A history of substance use disorder
- •Hypersensitivity to the active substance
- •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)
结局指标
主要结局
Difference in average total daily dose of opioids (morphine milligram equivalents) during the trial participation with particular focus on the last week prior to end of trial (EOT) comparatively between study participants receiving CBD and placebo, respectively
Difference in average total daily dose of opioids (morphine milligram equivalents) during the trial participation with particular focus on the last week prior to end of trial (EOT) comparatively between study participants receiving CBD and placebo, respectively
次要结局
- Difference in interference of pain on daily functioning by Brief Pain Inventory during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.Short Form (BPI-SF) Interference Items
- Difference in average total daily dose of non-opioid analgesics (e.g., NSAID, paracetamol, secondary analgesics) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
- Difference in use of concomitant therapy (e.g., radiation, corticosteroids) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
- Difference in quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 (EORTC-QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Prostate Cancer (EORTC-QLQ-PR25) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
- Difference in physical activity by average daily steps during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
- Difference in tumour activity by average serum prostate-specific antigen (PSA) and alkaline phosphatase (ALP) levels during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
- Difference in inflammation by average serum c-reactive protein (CRP), plasma cytokines and plasma soluble urokinase plasminogen activator receptor (suPAR) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
- Difference in average worst pain intensity on numeric rating scale (NRS) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
- Difference in safety profile outcomes by laboratory testing of routine blood samples and Common Terminology Criteria for Adverse Events (CTCAE 5.0) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
研究者
Peter Derek Christian Leutscher
Scientific
Regionshospital Nordjylland
研究点 (1)
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