ACTRN12622000083796招募中3 期
Medicinal Cannabis (MedCan 3) – a randomised, multicentre, double blind, placebo-controlled trial to assess THC/CBD (1:20) to relieve symptom burden in patients with cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 150
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
- Treatment
- 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 with advanced histologically proven cancer (metastatic or locally advanced) known to the palliative care team of the recruiting centre who:
- •-have an ESAS TSDS of 10 of higher for cancer-related symptoms*, and at least one individual ESAS score of 3 or higher (for sleep component need to have a sleep NRS score of 3 or higher)
- •-a Performance Status AKPS (Australia-modified Karnofsky Scale score) of at least 30
- •-are aged 18 years or older, 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
- •* physician assessed
排除标准
- •Patients with:
- •-a history of hypersensitivity to any cannabinoid
- •-unstable, untreated cardiovascular disease (hypertension, ischaemic heart disease, congestive cardiac failure)
- •-severe hepatic impairment (total bilirubin of 1.5 times or greater than the upper limit of the institution’s normal range, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 3.0 times or greater than the upper limit of the institution’s normal range. Subjects with liver metastasis may have an AST and ALT of up to 5.0 times the upper limit of normal)
- •-severe renal impairment (eGFR of 20mL/min/1.73m2 or greater)
- •-known allergy to nuts, coconut, avocado, sage or rosemary
- •-a history of psychosis, schizophrenia or severe mood disorders
- •-cognitive impairment (SLUMS - St Louis University Mental Status) examination equal to or less than 20/30.
- •-known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening Test) examination scoring greater than 27 for any substance
- •-history suggesting that drug diversion may be a risk for them or their family/carers
- •-females who are pregnant or lactating
- •-concurrent or participation in a trial of a new clinical entity within the last 28 days
- •-treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) or radiation within the last 7 days
研究者
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