ACTRN12623000878673招募中Unknown
Exploring potential anti-inflammatory effects of THC/CBD 1:20 medicinal cannabis product in patients with advanced cancer
Mater Misericordiae Limited0 个研究点目标入组 30 人开始时间: 2023年8月16日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients who consent and are eligible for MedCan 3 - THC/CBD 1:20 (ACTRN12622000083796).
- •Patients with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team of the recruiting centre who:
- •- Have an Edmonton Symptom Assessment System Total Symptoms Distress Score (ESAS TSDS) greater than or equal to 10 for cancer-related symptoms, and at least one individual ESAS score greater than or equal to 3 (for sleep component need to have a sleep numeric rating scale (NRS) score greater than or equal to 3)
- •- Performance Status AKPS (Australia-modified Karnofsky Scale score) of greater than or equal to 30
- •- Are aged 18 years, English-speaking (or have an interpreter available)
- •- Have a negative pregnancy urine test at eligibility (only if of reproductive potential) and agree to avoid pregnancy during the study and 12 weeks following the last dose of the study drug. Males must agree to avoid fathering a child and to not donate sperm during the study and for at least 12 weeks following the last dose of the study drug.
- •- Have a negative THC urine test at eligibility for previous cannabinoid use
- •- Are able to tolerate oral medications
- •- Are willing to receive standard palliative care as delivered by their primary treating team
- •- Can comply with all trial requirements: agree to attend scheduled clinic appointments, adhere to dose titration schedules as directed
- •- Agree to use no other cannabis-based products for the duration of the trial
- •- Understand that it is illegal to drive whilst taking THC containing cannabis products, to take cannabinoid products outside of Australia or to endorse legal documents whilst taking THC containing cannabis products
- •- Are able to provide fully informed consent
排除标准
- 未提供
研究者
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