NPC
Conditions
Keywords
EBV, EGCG
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.
Interventions
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_SUPPLEMENTPlacebo
Placebo qd (2# bid) for 3 years
Sponsors
Mackay Memorial Hospital
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
China Medical University Hospital
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EBV reactivation rates between EGCG and placebo group | every 3 months for the first 3 years and every 6 months thereafter for antibodies tests and pEBV DNA assay (total 5 years) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between EBV reactivation and OS/RFS | q 3 months for first 3 years and q 6 months for the | Observational analysis of the correlation between EBV reactivation and clinical outcome |
Countries
Taiwan
Outcome results
None listed