Clinical trial · Interventional
Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients
Study of Epstein-Barr Virus Reactivation and the Effect of Dietary Supplement Epigallocatechin Gallate (EGCG) on Virus Reactivation in Remission Patients With Nasopharyngeal Carcinoma - A Randomized Trial
NCT01744587CI-TRIAL-00093721NPCcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NPC | Nasopharyngeal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epigallocatechin Gallate (EGCG) | Other | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo qd (2# bid) for 3 years
- interventionNames
- Dietary Supplement: Placebo
- type
- EXPERIMENTAL
- label
- Epigallocatechin Gallate (EGCG)
- description
- EGCG 600 mg qd (2# bid) for 3 years
- interventionNames
- Other: Epigallocatechin Gallate (EGCG)
Primary outcomes (1)
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.