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Completed

NCT Number: NCT01224496

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

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.

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Key information

Conditions

Myelodysplastic Syndrome (MDS) Anemia Anemia, Aplastic Anemia, Hemolytic Anemia, Hemolytic, Congenital Aplastic Anaemia (AA) Bone Marrow Diseases Bone Marrow Failure Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Myelodysplastic Syndromes Myelofibrosis (MF) Myeloproliferative Disorders Primary Myelofibrosis Thalassemia Thalassemia Intermedia beta-Thalassemia

Age range

13 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Singapore General Hospital

Singapore, 169608

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chinese herbal concoction twice a day for 6 months

Drug

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

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 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 outcomes

  1. Quality of life

    Time frame: 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

  2. Haematological improvement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Shanghai Yueyang Integrated Medicine Hospital
  • Singapore Bao Zhong Tang TCM Center

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2010
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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