ACTRN12618001205224已完成1 期
An open label pilot study investigating safety, dosing and efficacy of cannabinoid medications for symptom relief in advanced cancer patients undergoing palliative care.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 25 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients with advanced histologically proven cancer (metastatic or locally advanced solid tumours or advanced haematological malignancies) who have been referred or known to the palliative care team who:
- •- have an ESAS TSDS >10
- •- at lease one individual ESAS score >3
- •- AKPS score >30
- •- aged >25yrs. English speaking (or interpreted available), give fully informed consent
- •- 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
- •- able to tolerate oral medication and comply with trial requirements
- •- agree to use no other cannabis based product
- •- understand it is illegal to drive a motor vehicle
排除标准
- •Patients with:
- •- a history of hypersensitivity to any cannabinoid product
- •- unstable untreated cardiovascular disease (hypertension, ischemic heart disease, congestive cardiac failure)
- •- severe hepatic impairment (total bilirubin >1.5 times the upper limit of the institution's normal range. Asparate aminotransferase (AST), and Alanine
- •aminotransferase (ALT) >3.0 time the upper limit. Subjects with liver metastasis may have an AST and ALT >5.0 time the upper limit
- •- severe renal impairment (eGFR <20mls/min/1.73m2)
- •- history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, schizophrenia, first degree relative with schizophrenia
- •and/or suicidal ideation)
- •- cognitive impairment (SLUMS - St Louis University Mental Status) examination <20/30; known substance use disorder (ASSIST - Alcohol, Smoking and
- •Substance Involvement Screening Test) examination score <27+; historyof drug diversion may be a risk for them or their family/carers
- •- females who are pregnant or lactating
- •- participation in a trial of a new clinical entity with the last 28 days
- •- treatment with a new specific anticancer agent (chemotherapy, targeted or hormonal therapy) within the last 21 days or radioation within the last 7 days
研究者
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