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

This study has been completed.
Sponsor:
Collaborators:
Shanghai Yueyang Hospital
Singapore Bao Zhong Tang TCM Center
Information provided by (Responsible Party):
Linn Yeh Ching, Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01224496
First received: October 3, 2010
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 38
Study Start Date: July 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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

  Eligibility

Ages Eligible for Study:   13 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224496

Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Shanghai Yueyang Hospital
Singapore Bao Zhong Tang TCM Center
  More Information

No publications provided by Singapore General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Linn Yeh Ching, dr, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01224496     History of Changes
Other Study ID Numbers: SHF/TCM002/2008
Study First Received: October 3, 2010
Last Updated: May 14, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore General Hospital:
Chronic cytopenic haematological diseases
Chinese herbal concoction
Supportive management

Additional relevant MeSH terms:
Primary Myelofibrosis
Anemia
Anemia, Aplastic
Beta-Thalassemia
Hematologic Diseases
Leukopenia
Myelodysplastic Syndromes
Preleukemia
Thalassemia
Thrombocytopenia
Myeloproliferative Disorders
Bone Marrow Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Leukocyte Disorders
Precancerous Conditions
Neoplasms
Blood Platelet Disorders

ClinicalTrials.gov processed this record on July 24, 2014