Clinical Trial: Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Traditional Chinese Medicine in the Supportive Management of Anaemic and Cytopenic (Leukopenia, Thrombocytopenia) Haematological Disorders
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.
Detailed Summary:
Sponsor: Singapore General Hospital
Current Primary Outcome: 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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
- 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.
Original Secondary Outcome: Same as current
Information By: Singapore General Hospital
Dates:
Date Received: October 3, 2010
Date Started: July 2009
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017