Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Singapore General Hospital
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Study Overview
Brief Summary
The purpose of this study is to study the efficacy of Traditional Chinese Medicine (TCM) on anaemic and cytopenic haematological disorders including myelodysplastic syndrome (MDS), aplastic anaemia (AA), myelofibrosis (MF) and thalassemia intermedia who do not have or did not respond to available treatment options.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 85 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A diagnosis of MDS, AA, MF or thal based on currently recognized diagnostic criteria.
- •Explored or undergone established therapies eg haemopoietic stem cell transplant, immunosuppressive therapy, chemotherapy, growth factors, thalidomide, hypomethylating agent or androgens, and (a) are deemed not suitable, or (b) refuse or (c) have failed therapy
- •A preceding follow up period (without or with treatment) of 2-4 months as baseline (depending on the severity of cytopenia) before being enrolled into this study
- •Understand the trial nature of this treatment, agree to be compliant to medication, do not self medicate and have signed informed consent
- •Agreeable to regular blood tests and follow up marrow study as listed in schedule
Exclusion Criteria
- •Life expectancy of shorter than one year
- •Significant organ failure including the following
- •Renal impairment with Cr above 200umol/L
- •Liver impairment with serum bilirubin > 2x upper limits or transaminase >3x upper limits
- •Escalation of treatment of introduction of new agents including growth factors, thalidomide, hypomethylating agents, immunosuppressive therapy or androgens once started on treatment with TCM is not allowed. Continuation of current therapy at same or lower doses is allowed
- •Women during pregnancy or lactation.
Arms & Interventions
Treatment with Chinese herbal concoction
Patients must have a marrow study to confirm diagnosis of MDS, AA or MF. MDS is classified according to the WHO criteria and scored according to IPSS. The AA group is further classified into AA, SAA or VSAA . MF is defined by the Italian criteria and risk stratified by the Lilles Scoring system. Diagnosis of thal intermedia and major is based on previously done Hb electrophoresis and severity of disease is assessed by degree of anaemia.and frequency of blood transfusions
TCM diagnosis: Syndrome differentiation according to TCM theory will be assessed as a baseline by experienced TCM collaborators and classified into one of the few defined syndromes as follows
- Yin deficiency of spleen and kidney
- Yang deficiency of spleen and kidney
- Deficiency of both Yin and Yang
- Stagnation of dampness and poison in the blood
- Excessive heat and poison
Intervention: Chinese herbal concoction twice a day for 6 months (Drug)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 6 months
The following parameters will be monitored serially 1. symptoms : ie reflection of any subjective symptoms that may be due to the treatment 2. Serial biochemistry ( urea, electrolyte, creatinine, liver function test ) will be done at baseline, one week into the study and then every 7-8 weekly till end of the 6 months. This will monitor for any organ toxicity
Secondary Outcomes
- Quality of life(6 months)
- Haematological improvement(6 months)