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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Health Research Institutes, Taiwan
Sponsor:
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
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01744587
First received: December 5, 2012
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
NPC
Other: Epigallocatechin Gallate (EGCG)
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: q 3 months for first 3 years and q 6 months for the ] [ Designated as safety issue: Yes ]
    Observational analysis of the correlation between EBV reactivation and clinical outcome


Estimated Enrollment: 352
Study Start Date: April 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo qd (2# bid) for 3 years
Dietary Supplement: Placebo
Placebo qd (2# bid) for 3 years
Other Name: Placebo
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 Name: EGCHAC-purified EGCG 90% capsules

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744587

Contacts
Contact: Jin Ch Lin, MD PHD +856-4-23592525 ext 5613 jclin@vghtc.gov.tw
Contact: Yung Hs Chin, MSN +886-37-246-166 ext 35119 yhchin@nhri.org.tw

Locations
Taiwan
Taiwan Cooperative Oncology Group, National Health Research Institutes Recruiting
Zhunan, Miaoli, Taiwan, 350
Contact: Jin Ch Lin, MD PHD    +8864-23592525 ext 5613    jclin@vghtc.gov.tw   
Contact: Tsang Wu Liu, MD    +886-37-246166 ext 35120    walter@nhri.org.tw   
Principal Investigator: Jin Ch Lin, MD PHD         
Principal Investigator: Yi Fa Chang, MD         
Principal Investigator: Wen Ch Chen, MD         
Principal Investigator: Jenn Re Hsiao, MD         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Mackay Memorial Hospital
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
Chang Gung Memorial Hospital
China Medical University Hospital
National Taiwan University 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
  More Information

No publications provided

Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT01744587     History of Changes
Other Study ID Numbers: T2312
Study First Received: December 5, 2012
Last Updated: October 28, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Health Research Institutes, Taiwan:
EBV
EGCG

Additional relevant MeSH terms:
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014