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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
NPC

Intervention / Treatment
-----------------
* Other: Epigallocatechin Gallate (EGCG)
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo qd (2# bid) for 3 years | Dietary Supplement: Placebo<br>* Placebo qd (2# bid) for 3 years<br>|
| Experimental: Epigallocatechin Gallate (EGCG)<br>EGCG 600 mg qd (2# bid) for 3 years | Other: Epigallocatechin Gallate (EGCG)<br>* EGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals.<br>* Other names: EGCHAC-purified EGCG 90% capsules;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between EBV reactivation and OS/RFS | Observational analysis of the correlation between EBV reactivation and clinical outcome | q 3 months for first 3 years and q 6 months for the | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EBV, EGCG