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

NCT01224496 | Completed Phase 1 DMC

• 1 other identifier: SHF/TCM002/2008
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chronic cytopenic haematological diseases; Chinese herbal concoction; Supportive management

Outcome Measures

Primary Outcomes (1)

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

  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

  6 months

Secondary Outcomes (2)

• Quality of life

  6 months

• Haematological improvement

  6 months

Study Arms (1)

Treatment with Chinese herbal concoction

EXPERIMENTAL

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

Interventions

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

Treatment with Chinese herbal concoction

Eligibility Criteria

• Age: 13 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Shanghai Yueyang Integrated Medicine Hospital: collaborator
• Singapore Bao Zhong Tang TCM Center: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore, 169608, Singapore

Location

Related Publications (1)

• Linn YC, Lu J, Lim LC, Sun H, Sun J, Zhou Y. Traditional Chinese herbal medicine in the supportive management of patients with chronic cytopaenic marrow diseases -- a phase I/II clinical study. Complement Ther Clin Pract. 2011 Aug;17(3):152-6. doi: 10.1016/j.ctcp.2011.01.004. Epub 2011 Feb 17.

  PMID: 21742281 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes; Anemia, Aplastic; Primary Myelofibrosis; beta-Thalassemia

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia; Bone Marrow Failure Disorders; Myeloproliferative Disorders; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2010
• First Posted: October 20, 2010
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

SG (1)