None listed
Conditions
Brief summary
Aims: This pilot trial aims to evaluate the safety and tolerability of a Traditional Chinese Medicine herbal combination “AL” (Astragalus membranaceus and Ligustrum lucidum) in people with advanced cancer. It will also investigate whether AL can improve the immune function Who is it for? You may be eligible to join this study if you are aged 18 years or older and have been diagnosed with recurrent or metastatic cancer or have declined or are ineligible for further treatment. Study details All participants in this study will receive AL herbal treatment and take 12 capsules of AL each day for 12 weeks. The study treatment is a combination of two herbal medicines known as “AL” (Astragalus membranaceous and Ligustrum lucidum). “AL” consists of herbal medicines, which have been used together for many years in China especially in people undergoing cancer treatment. “AL” is commonly available as a registered product in China called Zhenqi Fuzheng Capsule. This product is registered by the China State Drug Administrations as a prescribed medicine (Z62020414). At least 17 clinical studies have investigated this combination AL using this same product Zhenqi Fuzheng Capsule in people with cancer who have undergone standard chemotherapy or radiotherapy treatments. We know from studies in other people with cancer that “AL” is usually well tolerated. It is possible that “AL” may help lessen some of the side-effects of cancer treatment – but this is the focus of future studies. The results from this study will be used to design future studies looking at combining these herbal medicines with current treatments. Participant will complete fatigue and quality of life questionnaires, and donate blood for tests at baseline, during AL treatment and after.treatment The ability of participants to tolerate AL will be determined by their treating physician.
Interventions
The herbal combination “AL” is composed of 2 herbs (Astragalus membranaceus and Ligustrum lucidum) in a granule form but will be administered in the form of capsules.
For this study, the source of combination “AL”will be a commercially available product called “Zhenqi Fuzheng Capsule” (ZFC). ZFC is extracted by a herbal pharmaceutical company in China (Gansu Fuzheng Pharmaceutical Technology Co. Ltd). This product has been registered by China State Drug Administration as a prescribed medicine (Z
The herbal combination “AL” is composed of 2 herbs (Astragalus membranaceus and Ligustrum lucidum) in a granule form but will be administered in the form of capsules. For this study, the source of combination “AL”will be a commercially available product called “Zhenqi Fuzheng Capsule” (ZFC). ZFC is extracted by a herbal pharmaceutical company in China (Gansu Fuzheng Pharmaceutical Technology Co. Ltd). This product has been registered by China State Drug Administration as a prescribed medicine (Z62020987). This is a pilot multicentre open-labelled study. Consenting patients will receive 12 capsules of AL each day for 12 weeks. Each capsule contains 400mg of AL. Participants will complete fatigue and quality of life questionnaires, and donate blood for tests at the beginning of the study, during AL treatment and after 12 weeks of AL treatment. The ability of participants to tolerate AL will be determined by their treating physician. Known and possible side effect(s) for each arm of the trial (if applicable): Possible side effects (though uncommon as evidence relates to the intravenous use of this herbal combination given with cancer chemotherapy): - Skin eruption and itching - Hypertension - Headache, dizziness and chest distress - Insomnia Even less common side effects - Pain in limbs - Abdominal bloating, poor appetite and vomiting -Fever - Gum bleeding -Jaundice Adherence will be monitored by self-report at each assessment and returned pill count at the end of the study. Specifically full blood counts (FBC) including a differential will be obtained prior to AL treatment, during (2 weeks, and 6 weeks after starting) and after AL treatment (12 weeks) at the follow up visit in line with usual care. In addition immunological and inflammatory markers will be measured at these time points. A brief patient diary will be completed daily whilst on AL treatment to obtain information on toxicity The following questionnaires have all been well validated and are included to determine whether the measured symptoms are improved by the active treatment. -General Health Questionnaire (GHQ) 12 -Functional Assessment of Cancer Treatment Fatigue (FACT-F) In short, the study aims to determine the safety and tolerability of AL after 12 weeks of supplementation in patients with advanced cancer.
Sponsors
Concord Repatriation General Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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 - 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
Outcome results
None listed