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

Primary Purpose

NPC

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Epigallocatechin Gallate (EGCG)
Placebo
Sponsored by
National Health Research Institutes, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for NPC focused on measuring EBV, EGCG

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taiwan Cooperative Oncology Group, National Health Research Institutes

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Epigallocatechin Gallate (EGCG)

Arm Description

Placebo qd (2# bid) for 3 years

EGCG 600 mg qd (2# bid) for 3 years

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Correlation between EBV reactivation and OS/RFS
Observational analysis of the correlation between EBV reactivation and clinical outcome

Full Information

First Posted
December 5, 2012
Last Updated
September 13, 2018
Sponsor
National Health Research Institutes, Taiwan
Collaborators
Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, China Medical University Hospital, National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01744587
Brief Title
Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan
Collaborators
Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, China Medical University Hospital, National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NPC
Keywords
EBV, EGCG

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo qd (2# bid) for 3 years
Arm Title
Epigallocatechin Gallate (EGCG)
Arm Type
Experimental
Arm Description
EGCG 600 mg qd (2# bid) for 3 years
Intervention Type
Other
Intervention Name(s)
Epigallocatechin Gallate (EGCG)
Other Intervention Name(s)
EGCHAC-purified EGCG 90% capsules
Intervention Description
EGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo qd (2# bid) for 3 years
Primary Outcome Measure Information:
Title
EBV reactivation rates between EGCG and placebo group
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.
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)
Secondary Outcome Measure Information:
Title
Correlation between EBV reactivation and OS/RFS
Description
Observational analysis of the correlation between EBV reactivation and clinical outcome
Time Frame
q 3 months for first 3 years and q 6 months for the

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsang Wu Liu, MD
Organizational Affiliation
Taiwan Cooperative Oncology Group, National Health Research Institutes
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jin Ch Lin, MD PHD
Organizational Affiliation
Taichung Veterans General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jen Ya Chen, PHD
Organizational Affiliation
National Institute of Cancer Research, National Health Research Institutes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taiwan Cooperative Oncology Group, National Health Research Institutes
City
Zhunan
State/Province
Miaoli
ZIP/Postal Code
350
Country
Taiwan

12. IPD Sharing Statement

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

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