Study to evaluate safety and tolerability of a Traditional Chinese Herbal medicine combination AL” (Astragalus membranaceus and Ligustrum lucidum) in people with advanced cancer.
- Conditions
- CancerCancer - Any cancer
- Registration Number
- ACTRN12615001203549
- Lead Sponsor
- Concord Repatriation General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The first primary endpoint will be the proportion of participants to experience serious adverse effects (safety)..Safety will be assessed based on patient diaries, hematological and non-hematological toxicities, performance status; tolerability will be assessed by the treating physician and pill count[End of the study after 12 weeks of treatment];The second primary endpoint will be the proportion of participants to complete the study (tolerability) by review of patient diary and pill count[End of the study after 12 weeks of treatment]
- Secondary Outcome Measures
Name Time Method