ACTRN12615000414516撤回2 期
A Phase IIa Randomised Placebo Controlled Adjunctive Antiemetic Therapy With a Cannabinoid Extract in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Moderately to Highly Emetogenic Chemotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 224
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 meeting all of the following inclusion criteria will be included in the study:
- •1)Chemotherapy-naive patients receiving moderate-highly emetogenicity chemotherapy.
- •2)Males and females equal to or greater than 18 years old.
- •3)Life expectancy >3 months.
- •4)ECOG performance status equal to or less than 2.
- •5)Baseline Karnofsky score >60.
- •6)No concurrent neoplasms or illness that induces nausea independent of chemotherapy.
- •7)No self-prescribed therapies or complimentary products used for nausea such as ginger.
- •8)Receiving serotonin 5HT3 or NK1 receptor antagonist medications.
- •9)Can be reasonably expected to be able to complete the CINV assessment tools.
- •10)Have provided written informed consent
排除标准
- •1)Patients requiring radiotherapy.
- •2)Previous adverse reaction to or contraindicated to the standard anti-emetics proposed in the study.
- •3)Pregnant or breast-feeding.
- •4)Concurrent use of other cannabinoid-containing products.
- •5)History of adverse reactions to cannabinoids.
- •6)Patients with malignancies of gastrointestinal tract / gastrointestinal diseases or nausea and vomiting due to reasons other than chemotherapy.
- •7)Thrombocytopenia or patients undergoing chemotherapy that, according to physician discretion, is likely to cause thrombocytopenia (platelets <50 x 10^9/L).
- •8)Currently prescribed warfarin or on any other form of anti-coagulant therapy.
研究者
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