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临床试验/ACTRN12622000419763
ACTRN12622000419763尚未招募2 期

The CANnabinoids in CANcer (CANCAN) trial: Investigating the effect of medicinal cannabis on symptoms and side effects of chemotherapy in people with cancer

Central Adelaide Local Health Network (CALHN)0 个研究点目标入组 176 人开始时间: 2022年3月11日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
176

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
Prevention
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

  • 18 years of age or older
  • Scheduled to receive mucotoxic, systemic cancer therapy for advanced solid and haematological cancers.
  • Anticipated to undergo 3 cycles of chemotherapy (solid tumour cancer participants) OR autologous stem cell transplantation (haematological cancers – HSCT participants).
  • Willing to commit to not taking cannabis in any other form during the clinical trial period.
  • For randomisation of solid tumour participants: Gut distress symptoms related to their cancer therapy defined by a score of greater or equal to 1 in the MDQ and confirmed by research nurse.

排除标准

  • Cannabis dependence / misuse defined by the revised Cannabis Use Disorder Identification test score of 8 or above.
  • History of unstable cardiovascular disease including myocardial infarction or cerebrovascular accident, crescendo history of angina or heart failure.
  • Recreational or medicinal cannabis use defined as use >once/week in the month leading up to the clinical trial period.
  • History of psychosis secondary to, or intolerance to cannabis products.
  • Presence of an active psychiatric disorder or concurrent disorder that may be exacerbated by
  • cannabinoids, or which may interfere with clinical trial outcome determination (determined by the recruiting clinician).
  • Pregnant or planning on becoming pregnant.
  • Currently lactating.
  • Involved in another clinical trial (except observational trials) or expected to start one soon after completion.
  • Pre-existing oral disease or disability that would impair oral-administration or mucosal absorption.
  • Presence of known impairment of hepatic synthetic dysfunction.
  • Laboratory values suggestive of liver dysfunction.

研究者

发起方
Central Adelaide Local Health Network (CALHN)

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