ACTRN12615001203549
Recruiting
Phase 1
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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Concord Repatriation General Hospital
- Enrollment
- 25
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\-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
Outcomes
Primary Outcomes
Not specified
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