Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients
NCT ID: NCT01744587
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
353 participants
INTERVENTIONAL
2013-04-30
2023-05-16
Brief Summary
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Detailed Description
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Routine re-staging work-ups after RT should show no active lesion in nasopharynx, neck and distant organs. Re-staging survey should include nasopharyngoscope, pEBV DNA assay, CBC, platelet count, renal and liver function tests, CXR, abdominal sonography or CT scan, whole body bone scan, MRI or CT scan of the head and neck region.
Within one week after finishing registration, EGCG or placebo should be started. A blood sample before taking EGCG/placebo will be collected for antibodies test and pEBV DNA assay.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Placebo
Placebo qd (2# bid) for 3 years
Placebo
Placebo qd (2# bid) for 3 years
Epigallocatechin Gallate (EGCG)
EGCG 600 mg qd (2# bid) for 3 years
Epigallocatechin Gallate (EGCG)
EGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals.
Interventions
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Epigallocatechin Gallate (EGCG)
EGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals.
Placebo
Placebo qd (2# bid) for 3 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2010 AJCC stage II-IVB.
* Age ≧ 20 years old.
* Performance status of ECOG ≦ 2.
* Finished RT ≧66 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy).
* Clinical complete remission by re-staging work-ups within 3 months before entry.
* Plasma EBV DNA = 0 copy/ml within 4 weeks before entry.
* Adequate liver, renal, and bone marrow function:Serum total bilirubin level ≦ 2.5 mg/dl. Serum creatinine ≦ 1.6 mg/dl. WBC ≧ 3,000/ul. Platelet count ≧ 100,000/ul.
* No intake of EGCG or similar dietary supplements.
* Signed informed consent.
* No further anti-cancer treatment.
Exclusion Criteria
* Inadequate RT or finishing RT \> 6 months.
* Not complete remission by re-staging work-ups within 3 months before entry.
* Plasma EBV DNA \> 0 copy/ml within 4 weeks before entry.
* Intake of EGCG or similar dietary supplements during recent 3 months.
* Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
20 Years
ALL
No
Sponsors
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Mackay Memorial Hospital
OTHER
Taichung Veterans General Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
China Medical University Hospital
OTHER
National Taiwan University Hospital
OTHER
National Health Research Institutes, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Tsang Wu Liu, MD
Role: STUDY_DIRECTOR
Taiwan Cooperative Oncology Group, National Health Research Institutes
Jin Ch Lin, MD PHD
Role: PRINCIPAL_INVESTIGATOR
Taichung Veterans General Hospital
Jen Ya Chen, PHD
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cancer Research, National Health Research Institutes
Locations
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Taiwan Cooperative Oncology Group, National Health Research Institutes
Zhunan, Miaoli, Taiwan
Countries
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Other Identifiers
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T2312
Identifier Type: -
Identifier Source: org_study_id
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