Aplastic Anaemia (AA), Myelodysplastic Syndrome (MDS), Myelofibrosis (MF), Thalassemia Intermedia
Conditions
Keywords
Chronic cytopenic haematological diseases, Chinese herbal concoction, Supportive management
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.
Interventions
DRUGChinese herbal concoction twice a day for 6 months
Definition of each TCM syndrome is based on TCM theory. Formulation composition is based on each defined TCM syndrome with addition or removal of herbs as indicated by the patient's manifestation
Sponsors
Shanghai Yueyang Integrated Medicine Hospital
Singapore Bao Zhong Tang TCM Center
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. A diagnosis of MDS, AA, MF or thal based on currently recognized diagnostic criteria. 2. 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 3. 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 4. Understand the trial nature of this treatment, agree to be compliant to medication, do not self medicate and have signed informed consent 5. Agreeable to regular blood tests and follow up marrow study as listed in schedule
Exclusion criteria
1. Life expectancy of shorter than one year 2. Significant organ failure including the following 3. Renal impairment with Cr above 200umol/L 4. Liver impairment with serum bilirubin \> 2x upper limits or transaminase \>3x upper limits 5. 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 6. Women during pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 6 months | Quality of life (QOL) will be measured based on the EORTC QLQ C30. THis will be taken at enrolment and at 2 monthly intervals |
| Haematological improvement | 6 months | The haematological response crietria is based on those published as follows For MDS : Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood 2000 Dec 1;96(12):3671-4. For MF : Response criteria for myelofibrosis with myeloid metaplasia: results of an initiative of the European Myelofibrosis Network (EUMNET). Blood 2005 Oct 15;106(8):2849-53. For AA : Aplastic Anemia, Pathophysiology and Treatment. Cambridge: Cambridge University Press; 2000. |
Countries
Singapore
Outcome results
None listed