Clinical trial NCT01224496: Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders
Official title: Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndrome (MDS)
Aplastic Anaemia (AA)
Myelofibrosis (MF)
Thalassemia Intermedia
Keywords: Chronic cytopenic haematological diseases
Chinese herbal concoction
Supportive management
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Yueyang Integrated Medicine Hospital
name: Singapore Bao Zhong Tang TCM Center
First posted: 2010-10-20
Enrollment: 38
Sex: ALL
Minimum age (years): 13
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: 6 months
measure: Haematological improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
citation: 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.