Efficacy of Green Tea Polyphenols on Myelodysplastic Syndromes: A Double-Blind Placebo-Controlled Phase II Randomised Clinical Trial

INTERVENTION: This study is a randomised phase II, 48 weeks clinical trial, with four parallel arms conducted under double‐blind and placebo‐controlled conditions on 200 MDS participants aged 18 years or more. The trial will be stratified into 100 patients with lower risk (low and intermediate‐1) disease, and 100 with higher risk (intermediate‐2 and high) disease, according to the International Prognostic Scoring System. The conventional treatment for lower risk group will be compound Zaofan pills (CZP), a form of traditional Chinese medicine, 1800mg/d with three meals. For higher risk group the conventional treatment will be the CAG regimen (aclarubicin 10 mg/day, days 1‐8; cytosine arabinoside 50 mg/day, days 1‐14; G‐CSF 300 ug/day, days 1‐14), which has been widely used for the treatment of MDS in China and Japan. Arm 1: Lower risk stratum 50 patients: GTPs capsule 1400mg/d (700mg/capsule, twice per day with morning and evening meals) for 48wks + conventional treatment Arm 2: Lower risk stratum 50 patients: Placebo 1400mg/d (700mg/capsule, twice per day with morning and evening meals) for 48wks + conventional treatment Arm 3: Higher risk stratum 50 patients: GTPs 1400mg/d (700mg/capsule, twice per day with morning and evening meals) for 48wks+ conventional treatment Arm 4: Higher risk stratum 50 patients: Placebo 1400mg/d (700mg/capsule, twice per day with morning and evening meals) for 48wks + conventional treatment CONDITION: myelodysplastic syndromes (MDS) PRIMARY OUTCOME: Primary Outcome 1: Altering the natural history of the disease collected from medical records including peripheral blood tests and bone marrow examinations. ; Number of participants with Complete Remission (CR): less than or equal to 5% marrow blasts without evidence of dysplasia and normalisation of peripheral blood counts, including Hb equal to or greater than 11g/dL (not receiving erythropoietin or transfusions), neutrophil count equal to or greater than 1.5x109/L, and platelet count equal to or greater than 100x109/L; ; Number of participants with Partial Remission: patients must demonstrate all CR criteria if abnormal before treatment except marrow blasts decrease equal to or greater than 50% compared with pre‐treatment levels; or patients may demonstrate a less‐advanced MDS disease classification category than prior to treatment. Primary Outcome 2: Hematologic improvement (HI) collected from medical records of peripheral blood tests. ; Improvement includes erythroid (HI‐E), platelet (HI‐P), and neutrophil (HI‐N). SECONDARY OUTCOME: Secondary Outcome 1: Overall survival, duration of hospitalization and progression into AML available from medical records. Secondary Outcome 2: Cytogenetic response collected from medical records of bone marrow examinations. ; Major cytogenetic response: disappearance of a cytogenetic abnormality; ; Minor cytogenetic response: 50% or more reduction of abnormal metaphases. Secondary Outcome 3: Quality of life measured by EORTC QLQ‐C30 version 3.0. INCLUSION CRITERIA: Newly diagnosed as MDS by WHO 2008 criteria; Age is 18 years or over; ECOG performance status less than or equal to 2; Protocol defined adequate hepatic and renal function; Willing to refrain from drinking any kind of tea for the duration of the study; Written informed consent; And intending to reside in the state during study period.