Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders

Singapore Health Services (SingHealth)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Thalassemia Intermedia; Myelofibrosis (MF); Myelodysplastic Syndrome (MDS); Aplastic Anaemia (AA)

Treatments: Drug: Chinese herbal concoction twice a day for 6 months

Study type: Interventional

Funder types: Other

Identifiers

NCT01224496

SHF/TCM002/2008

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 13 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Treatment with Chinese herbal concoction

Experimental group

Description:

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 1. Yin deficiency of spleen and kidney 2. Yang deficiency of spleen and kidney 3. Deficiency of both Yin and Yang 4. Stagnation of dampness and poison in the blood 5. Excessive heat and poison

Treatment:

Drug: Chinese herbal concoction twice a day for 6 months