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

Sponsor

Singapore General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01224496

Collaborator

Shanghai Yueyang Integrated Medicine Hospital (Other), Singapore Bao Zhong Tang TCM Center (Other)

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome (MDS) Aplastic Anaemia (AA) Myelofibrosis (MF) Thalassemia Intermedia	Drug: Chinese herbal concoction twice a day for 6 months	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Chinese 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

Arm

Intervention/Treatment

Experimental: 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

Drug: Chinese 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

Outcome Measures

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [6 months]
The following parameters will be monitored serially symptoms : ie reflection of any subjective symptoms that may be due to the treatment 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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.