Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000808842
Ethics application status
Approved
Date submitted
23/07/2012
Date registered
2/08/2012
Date last updated
3/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Green Tea Polyphenols on Myelodysplastic Syndromes: A Double-Blind Placebo-Controlled Phase II Randomised Clinical Trial
Scientific title
A phase II double-blind and placebo-controlled randomised clinical trial to determine the efficacy of Green Tea Polyphenols on 200 myelodysplastic syndromes participants
Secondary ID [1] 280898 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
GTPs on MDS RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myelodysplastic syndromes (MDS) 286969 0
Condition category
Condition code
Blood 287310 287310 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 285328 0
Treatment: Other
Comparator / control treatment
Placebo control: placebo will be capsules filled with 700mg of GT-colored microcrystalline cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 287586 0
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.
Timepoint [1] 287586 0
Timepoints: at 12, 24, 36 and 48weeks after intervention commencement.
Primary outcome [2] 287587 0
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).
Timepoint [2] 287587 0
Timepoints: at 12, 24, 36 and 48weeks after intervention commencement.
Secondary outcome [1] 298458 0
Secondary Outcome 1: Overall survival, duration of hospitalization and progression into AML available from medical records.
Timepoint [1] 298458 0
Timepoints: at 12, 24, 36 and 48wk after intervention commencement.
Secondary outcome [2] 298459 0
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.
Timepoint [2] 298459 0
Timepoints: at 12, 24, 36 and 48wk after intervention commencement.
Secondary outcome [3] 298460 0
Secondary Outcome 3: Quality of life measured by EORTC QLQ-C30 version 3.0.
Timepoint [3] 298460 0
Timepoints: at baseline and at 12, 24, 36 and 48weeks after intervention commencement.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Registration: This will be undertaken by the trial coordinator upon referrals from participating clinicians. It will include obtaining the consent of participants, screening of the patients, provision of information about trial logistics; randomisation, recording of baseline data; and issuing of the first 12-wk supply of treatment capsules from the pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur through pre-arranged blinded sequences of supplies of treatment capsules collected by the trial coordinator from the Hospital Pharmacy Department. An allocation and dispensing sequence numbers will be available for the trial participants in a uniform 1:1 allocation ratio, using a fixed Moses-Oakford algorithm and a variable block size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
14/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4421 0
China
State/province [1] 4421 0
Zhejiang Province

Funding & Sponsors
Funding source category [1] 285688 0
University
Name [1] 285688 0
The University of Western Australia
Country [1] 285688 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 284566 0
University
Name [1] 284566 0
School of Population Health , The University of Western Australia
Address [1] 284566 0
School of Population Health, The University of Western Australia, M431, 35 Stirling Highway, Crawley WA 6009
Country [1] 284566 0
Australia
Other collaborator category [1] 276973 0
Hospital
Name [1] 276973 0
The First Affiliated Hospital of College of Medicine, Zhejiang University, P. R. China
Address [1] 276973 0
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, 310003, P. R. China
Country [1] 276973 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287676 0
Human Research Ethics Committee of The University of Western Australia
Ethics committee address [1] 287676 0
Human Research Ethics Office
Research Services
35 Stirling Highway, Crawley, WA 6009
Ethics committee country [1] 287676 0
Australia
Date submitted for ethics approval [1] 287676 0
23/07/2012
Approval date [1] 287676 0
Ethics approval number [1] 287676 0
Ethics committee name [2] 287677 0
Human Research Ethics Committee of the First Affiliated Hospital of College of Medicine, Zhejiang University.
Ethics committee address [2] 287677 0
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou,
Ethics committee country [2] 287677 0
China
Date submitted for ethics approval [2] 287677 0
25/07/2012
Approval date [2] 287677 0
Ethics approval number [2] 287677 0

Summary
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.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 34476 0
Address 34476 0
Country 34476 0
Phone 34476 0
Fax 34476 0
Email 34476 0
Contact person for public queries
Name 17723 0
Dr Min Zhang
Address 17723 0
School of Population Health,
The University of Western Australia (M431)
35 Stirling Hwy
CRAWLEY WA 6009
Country 17723 0
Australia
Phone 17723 0
+61 8 64888175
Fax 17723 0
+61 8 64888188
Email 17723 0
[email protected]
Contact person for scientific queries
Name 8651 0
Dr Min Zhang
Address 8651 0
School of Population Health,
The University of Western Australia (M431)
35 Stirling Hwy
CRAWLEY WA 6009
Country 8651 0
Australia
Phone 8651 0
+61 8 64888175
Fax 8651 0
+61 8 64888188
Email 8651 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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