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

Myelodysplastic Syndrome (MDS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224496
• Other study ID #: SHF/TCM002/2008
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 3, 2010
• Last updated: February 9, 2017
• Start date: July 2009
• Est. completion date: August 2011

Study information

• Verified date: February 2017
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Aplastic
• Aplastic Anaemia (AA)
• beta-Thalassemia
• Hematologic Diseases
• Leukopenia
• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Myelofibrosis (MF)
• Preleukemia
• Primary Myelofibrosis
• Thalassemia
• Thalassemia Intermedia
• Thrombocytopenia

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Singapore General Hospital	Shanghai Yueyang Integrated Medicine Hospital, Singapore Bao Zhong Tang TCM Center

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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	6 months
Secondary	Quality of life	Quality of life (QOL) will be measured based on the EORTC QLQ C30. THis will be taken at enrolment and at 2 monthly intervals	6 months
Secondary	Haematological improvement	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.	6 months