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
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
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)
Tsang Wu Liu, MD
Taiwan Cooperative Oncology Group, National Health Research Institutes
Taiwan: Institutional Review Board