ACTRN12615001203549招募中1 期
Pilot study to evaluate the safety and tolerability of a Traditional Chinese Medicine herbal combination AL” (Astragalus membranaceus and Ligustrum lucidum) in people with advanced cancer.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Diagnosis of recurrent or metastatic cancer
- •-Aged greater than or equal to 18 years
- •-Ability to understand spoken and written English (to understand the study, provide informed consent and enable completion of self-report QOL questionnaires) or access to an appropriate translator
- •-Give written informed consent
- •-Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients entering this trial will be available for complete documentation of the treatment, adverse events, and follow up
- •-Able to swallow capsules WHOLE
排除标准
- •-Currently undergoing chemotherapy including palliative chemotherapy
- •-ECOG Performance Status of greater than or equal to 3
- •-Life expectancy is less than or equal to 12 weeks
- •-Inadequate haematopoetic function (WBC < 3.0 x 10^9/L; ANC < 1.5 x 10^9/L, platelets < 100 x 10^9/dL), or renal function (eGFR < 50 mL/min/1.73m2)
- •-Inadequate hepatic function (either AST/ALT > 2.5 x ULN, or > 5 x ULN in case of liver metastases, or bilirubin > 1.5 x ULN)
- •-Any major pre-existing psychiatric history or dementia that (in the view of the investigator) would interfere with the ability to provide informed consent and/or compliance with study procedures
- •-Pregnant or lactating women
- •-Cerebral or leptomeningeal metastases that are unstable in spite of cranial radiotherapy &/or stereotactic radiosurgery
- •-Serious intercurrent medical illness including (but not restricted to) HIV, active infection, unstable angina, severe heart failure, or ongoing surgical complications
- •-Major surgery within 2 weeks prior to study commencement
- •-Concurrent Radiotherapy
- •-Clinical evidence of current or impending bowel obstruction
- •-Reluctance or inability to cease other Traditional Chinese or other herbal, homeopathic or naturopathic medicines at least a week prior to trial commencement
- •-Documented allergy to study compounds
- •-Patients must not be participating in (or planning to participate in) trials of other pharmacological agents during their time on this study
- •-Concurrent use of immune-modulators
研究者
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