ACTRN12619001534178招募中1 期
A phase I/II double-blind, randomised controlled trial assessing effect of medicinal cannabis on quality of life and symptom control in advanced cancer.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 119
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
- •*Able to provide written informed consent and greater than or equal to 18 years of age.
- •*Willing and able to comply with all study requirements, including treatment, blood sampling and other assessments.
- •*Patients with incurable advanced cancer, of any histological subtype.
- •*Life expectancy greater than 2 months.
- •*ECOG 0-2
- •*Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication and use a medically acceptable form of contraception.
排除标准
- •1.Patients with recent change to systemic anticancer treatment (chemotherapy, immunotherapy, targeted therapy, hormonal therapy). The following time intervals are relative to the first day of study therapy:
- •Commenced new anticancer treatment within the last 14 days
- •Completed anticancer treatment <14 days ago
- •Planning to receive new anticancer treatment in the next 30 days
- •2.Having current radiotherapy, completed radiotherapy <14 days prior to first day of study therapy, or planning to have radiotherapy in the next 30 days
- •3.Severe hepatic impairment, as defined by:
- •aspartate aminotransferase (AST) >5 times upper limit of normal, or
- •alanine aminotransferase (ALT) >5 times upper limit of normal
- •4.Conditions preventing adequate absorption of study drug (including difficulty swallowing medications, intestinal obstruction, inflammatory bowel condition, colitis)
- •5.Inadequate renal function, defined as eGFR <30ml/min (using CKD-EPI calculation)
- •6.Substance use disorder (ICD-10 criteria (abuse, dependence) to alcohol, opioids, benzodiazepines, or illicit stimulants
- •7.Current or recent use of cannabis within 30 days prior to study entry. Participants must return a negative cannabis urine test.
- •8.Prior clinically significant adverse reaction to cannabis or cannabinoid based medications.
- •9.Unwilling to avoid driving or operating machinery whilst on trial.
- •10.Prior hypersensitivity or intolerable adverse reaction to cannabis or cannabinoid based medications. Patients on strong CYP3A4 inducers or inhibitors, or on strong CYP2C19 inducers or inhibitors (refer to Appendix 3).
- •11.Psychiatric or neurodegenerative condition which in the opinion of the investigator may compromise patient safety.
- •12.Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a highly effective and reliable means of contraception. Male participants must have been surgically sterilised or use a (double if required) barrier method of contraception.
- •13.Actively receiving a concurrent investigational product.
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