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

NPC Clinical Trial

— NPC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01744587
• Other study ID #: T2312
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 353
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• NPC

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taiwan Cooperative Oncology Group, National Health Research Institutes	Zhunan	Miaoli

Sponsors (7)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	Chang Gung Memorial Hospital, China Medical University Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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