Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients (NCT01744587) | Clinical Trial Compass
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 range20 Years
SexALL
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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.
What they're measuring
1
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