BACKGROUND Despite improvements in medical care, patients with advanced cancer still experience substantial symptom distress. There is increasing interest in the use of medicinal cannabinoids, but there is little high quality evidence to guide clinicians. This study aims to define the role of cannabidiol (CBD) in the management of symptom burden in patients with advanced cancer undergoing standard palliative care. METHODS AND DESIGN This study is a multicentre, randomised, placebo controlled, two arm, parallel trial of escalating doses of oral CBD. It will compare efficacy and safety outcomes of a titrated dose of CBD (100 mg/mL formulation, dose range 50 mg to 600 mg per day) against placebo. There is a 2-week patient determined titration phase, using escalating doses of CBD or placebo to reach a dose that achieves symptom relief with tolerable side effects. This is then followed by a further 2-week assessment period on the stable dose determined in collaboration with clinicians. DISCUSSION A major strength of this study is that it will target symptom burden as a whole, rather than just individual symptoms, in an attempt to describe the general improvement in wellbeing previously reported by some patients in open label, non controlled trials of medicinal cannabis. Randomisation with placebo is essential because of the well-documented over reporting of benefit in uncontrolled trials and high placebo response rates in cancer pain trials. This will be the first placebo controlled clinical trial to evaluate rigorously the efficacy, safety and acceptability of CBD for symptom relief in advanced cancer patients. This study will provide the medical community with evidence to present to patients wishing to access medicinal cannabis for their cancer related symptoms. TRIAL REGISTRATION NUMBER ALCTRN12618001220257 Registered 20/07/2018.

中文翻译：

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口服药用大麻素可减轻晚期癌症患者姑息治疗中的症状负担：一项关于大麻二酚（CBD）功效和安全性的双盲、安慰剂对照、随机临床试验。


背景技术尽管医疗保健有所改善，晚期癌症患者仍然经历严重的症状困扰。人们对药用大麻素的使用越来越感兴趣，但几乎没有高质量的证据来指导临床医生。本研究旨在明确大麻二酚（CBD）在接受标准姑息治疗的晚期癌症患者症状负担管理中的作用。方法和设计这项研究是一项多中心、随机、安慰剂对照、双臂、平行试验，口服 CBD 剂量递增。它将比较滴定剂量的 CBD（100 毫克/毫升制剂，剂量范围为每天 50 毫克至 600 毫克）与安慰剂的功效和安全性结果。有一个为期 2 周的患者确定滴定阶段，使用递增剂量的 CBD 或安慰剂来达到缓解症状且副作用可忍受的剂量。接下来是与临床医生合作确定的稳定剂量的另外两周评估期。讨论 这项研究的一个主要优点是，它将针对整个症状负担，而不仅仅是个别症状，试图描述一些患者之前在药用大麻的开放标签、非对照试验中报告的健康状况的总体改善。安慰剂的随机化至关重要，因为在非对照试验中过度报告了获益，并且在癌症疼痛试验中安慰剂反应率很高。这将是第一个安慰剂对照临床试验，旨在严格评估 CBD 对晚期癌症患者症状缓解的功效、安全性和可接受性。这项研究将为医学界提供证据，向希望使用药用大麻治疗癌症相关症状的患者提供证据。 试用注册号 ALCTRN12618001220257 注册日期：2018 年 7 月 20 日。