Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
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DOI：
10.1186/s13063-020-04541-6
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发表时间：
2020-07-06
期刊：
影响因子：
2.5
通讯作者：
Good, Phillip
中科院分区：
文献类型：
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作者：
Hardy, Janet;Haywood, Alison;Good, Phillip
背景尽管医疗水平不断提高，晚期癌症患者仍然会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，但很少有高质量的证据来指导临床医生。本研究的目的是定义的作用1：1的δ-9-四氢大麻酚/大麻二酚（THC/CBD）大麻素制剂在管理的症状负担的晚期癌症患者进行标准姑息治疗。方法和designOne百五十名参与者将被招募从五个网站内的昆士兰州姑息治疗研究组（QPCRG）和随机分配到一个积极的治疗或安慰剂组。这项研究是一项务实的多中心、随机、安慰剂对照、双臂试验，研究剂量递增的口服1：1 THC/CBD大麻素制剂。将比较滴定剂量（10 mg/10 mg/mL口服溶液制剂，剂量范围2.5 mg/2.5 mg-30 mg/30 mg/天）与安慰剂的疗效和安全性结局。有一个为期2周的患者确定的滴定阶段，使用1：1 THC/CBD或安慰剂的递增剂量，以达到缓解症状并具有可耐受副作用的剂量。然后，在与临床医生合作确定的稳定剂量上进行另外2周的评估期。主要目的是评估1：1 THC/CBD大麻素制剂对安慰剂的剂量递增对总症状评分变化的影响，次要目的包括建立患者确定的有效剂量，总身体和情绪疼痛的变化，变化的全球印象，焦虑和抑郁，阿片类药物的使用，生活质量和不良反应。DiscussionThis将是第一个安慰剂对照临床试验，严格评估1：1 THC/CBD缓解晚期癌症患者症状的疗效，安全性和可接受性。这项研究将使医学界有一些证据，目前希望获得大麻的患者对他们的症状所造成的晚期malignancy.Trial registrationACTRN，ACTRN 12619000037101。于2019年1月14日注册。试验申办者：Mater Misericorphine Limited（MML）和Mater Medical Research Institute Limited（MMRI）-雷蒙台，南布里斯班，布里斯班，昆士兰州，澳大利亚
BackgroundDespite improvements in medical care, patients with advanced cancer still experience substantial symptom distress. There is increasing interest in the use of medicinal cannabinoids but little high-quality evidence to guide clinicians. This study aims to define the role of a 1:1 delta-9-tetrahydrocannabinol/cannabidiol (THC/CBD) cannabinoid preparation in the management of symptom burden in patients with advanced cancer undergoing standard palliative care.Methods and designOne hundred fifty participants will be recruited from five sites within the Queensland Palliative Care Research Group (QPCRG) and randomly assigned to an active treatment or placebo group. This study is a pragmatic multicentre, randomised, placebo-controlled, two-arm trial of escalating doses of an oral 1:1 THC/CBD cannabinoid preparation. It will compare efficacy and safety outcomes of a titrated dose (10mg/10mg/mL oral solution formulation, dose range 2.5mg/2.5mg-30mg/30mg/day) against placebo. There is a 2-week patient-determined titration phase, using escalating doses of 1:1 THC/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. The primary objective is to assess the effect of escalating doses of a 1:1 THC/CBD cannabinoid preparation against placebo on change in total symptom score, with secondary objectives including establishing a patient-determined effective dose, the change in total physical and emotional sores, global impression of change, anxiety and depression, opioid use, quality of life and adverse effects.DiscussionThis will be the first placebo-controlled clinical trial to rigorously evaluate the efficacy, safety and acceptability of 1:1 THC/CBD for symptom relief in advanced cancer patients. This study will allow the medical community to have some evidence to present to patients wishing to access cannabis for their symptoms caused by advanced malignancy.Trial registrationACTRN, ACTRN12619000037101. Registered on 14 January 2019.Trial Sponsor: Mater Misericordiae Limited (MML) and Mater Medical Research Institute Limited (MMRI)-Raymond Terrace, South Brisbane, Brisbane, QLD, Australia