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
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