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

September 13, 2018 updated by: National Health Research Institutes, Taiwan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

353

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Miaoli
      • Zhunan, Miaoli, Taiwan, 350
        • Taiwan Cooperative Oncology Group, National Health Research Institutes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo qd (2# bid) for 3 years
Dietary supplement: Placebo
Placebo qd (2# bid) for 3 years
EXPERIMENTAL: Epigallocatechin Gallate (EGCG)
EGCG 600 mg qd (2# bid) for 3 years
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.
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
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)

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
Time Frame: q 3 months for first 3 years and q 6 months for the
Observational analysis of the correlation between EBV reactivation and clinical outcome
q 3 months for first 3 years and q 6 months for the

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Collaborators

National Taiwan University Hospital
Mackay Memorial Hospital
China Medical University Hospital
Chang Gung Memorial Hospital
National Cheng-Kung University Hospital
Taichung Veterans General Hospital

Investigators

  • Study Director: Tsang Wu Liu, MD, Taiwan Cooperative Oncology Group, National Health Research Institutes
  • Principal Investigator: Jin Ch Lin, MD PHD, Taichung Veterans General Hospital
  • Principal Investigator: Jen Ya Chen, PHD, National Institute of Cancer Research, National Health Research Institutes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 5, 2012

First Posted (ESTIMATE)

December 6, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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