NCT01744587

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with pathologically proven NPC, stage II-IVB and finishing curative RT ≧70 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy) will be candidates for this study. Before entry, 8 CC venous blood will be obtained for EBV DNA and antibody screen tests after patient's consent. Those who have undetectable plasma EBV DNA (0 copy/ml) and fulfilled with all inclusion and exclusion criteria will be registered. 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

• NPC

Interventions

Type	Name	Description
OTHER	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.
DIETARY_SUPPLEMENT	Placebo	Placebo qd (2# bid) for 3 years

Timeline

• Start date: 2013-04-01
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2012-12-06
• Last updated: 2025-08-15

Locations

1 site across 1 country: Taiwan