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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


Phase 2/Phase 3
20 Years
N/A
Not Enrolling
Both
NPC

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Trial Information

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.


Inclusion Criteria:



- Histologically proven NPC.

- 2010 AJCC stage II-IVB.

- Age ≧ 20 years old.

- Performance status of ECOG ≦ 2.

- Finished RT ≧70 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Outcome Measure:

EBV reactivation rates between EGCG and placebo group

Outcome Description:

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.

Outcome Time Frame:

every 3 months for the first 3 years and every 6 months thereafter for antibodies tests and pEBV DNA assay (total 5 years)

Safety Issue:

Yes

Principal Investigator

Tsang Wu Liu, MD

Investigator Role:

Study Director

Investigator Affiliation:

Taiwan Cooperative Oncology Group, National Health Research Institutes

Authority:

Taiwan: Institutional Review Board

Study ID:

T2312

NCT ID:

NCT01744587

Start Date:

December 2012

Completion Date:

December 2020

Related Keywords:

  • NPC
  • EBV
  • EGCG

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