Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients

NCT01744587 | Completed DMC

• 1 other identifier: T2312
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the EBV reactivation rate in post-radiation and remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the observational correlation between EBV reactivation and clinical outcome.

Conditions

NPC

Keywords

EBV; EGCG

Outcome Measures

Primary Outcomes (1)

• EBV reactivation rates between EGCG and placebo group

  Reactivation of EBV is defined as 1.Antibody against EBV VCA: The IgA antibody titers will be detected by a commercial EBV VCA ELISA kit (RE 562 71, Immuno-Biological Laboratories, Germany) Patient's serum with anti-EBV VCA greater than 10U/ml will be considered as reactivation of EBV.

  every 3 months for the first 3 years and every 6 months thereafter for antibodies tests and pEBV DNA assay (total 5 years)

Secondary Outcomes (1)

• Correlation between EBV reactivation and OS/RFS

  q 3 months for first 3 years and q 6 months for the

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo qd (2# bid) for 3 years

Dietary Supplement: Placebo

Epigallocatechin Gallate (EGCG)

EXPERIMENTAL

EGCG 600 mg qd (2# bid) for 3 years

Other: Epigallocatechin Gallate (EGCG)

Interventions

Epigallocatechin Gallate (EGCG) OTHER

EGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals.

Also known as: EGCHAC-purified EGCG 90% capsules

Epigallocatechin Gallate (EGCG)

Placebo DIETARY_SUPPLEMENT

Placebo qd (2# bid) for 3 years

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven NPC.
• 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.

You may not qualify if:

• Occurrence of locoregional recurrence or distant metastasis.
• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Mackay Memorial Hospital: collaborator
• Taichung Veterans General Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• China Medical University Hospital: collaborator
• National Taiwan University Hospital: collaborator

Study Sites (1)

Taiwan Cooperative Oncology Group, National Health Research Institutes

Zhunan, Miaoli, 350, Taiwan

Location

MeSH Terms

Interventions

epigallocatechin gallate

Study Officials

• Tsang Wu Liu, MD

  Taiwan Cooperative Oncology Group, National Health Research Institutes

  STUDY DIRECTOR

• Jin Ch Lin, MD PHD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

• Jen Ya Chen, PHD

  National Institute of Cancer Research, National Health Research Institutes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 6, 2012
• Study Start: April 1, 2013
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

TW (1)