CompletedNot Applicable

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

Taiwan353 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically proven NPC. * 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: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

EBV reactivation rates between EGCG and placebo group

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

Trial details

NCT IDNCT01744587

SponsorNational Health Research Institutes, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-16

View on ClinicalTrials.gov More NPC trials

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.