None listed
Conditions
Brief summary
Laboratory evidence and observational epidemiological studies show that GTPs protect against cancer. This study aims to assess the efficacy of GTPs in MDS patients by comparing pre-post differences in results of hematological markers of disease activity and quality of life between intervention and placebo patient groups.
Interventions
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 f
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
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Lack of, or withdrawal of, informed consent; Significant hematological co-morbidities, hepatic failure, renal failure or severe cardiovascular disease; Pregnant or positive pregnancy test or child-bearing; Participation in another trial; Or history of any cancer.
Outcome results
None listed