Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients (NPC)
|NPC||Other: Epigallocatechin Gallate (EGCG) Dietary Supplement: Placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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|
- 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.
- 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
|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)|
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 Name: EGCHAC-purified EGCG 90% capsules
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744587
|Contact: Jin Ch Lin, MD PHD||+856-4-23592525 ext email@example.com|
|Contact: Yung Hs Chin, MSN||+886-37-246-166 ext firstname.lastname@example.org|
|Taiwan Cooperative Oncology Group, National Health Research Institutes||Recruiting|
|Zhunan, Miaoli, Taiwan, 350|
|Contact: Jin Ch Lin, MD PHD +8864-23592525 ext 5613 email@example.com|
|Contact: Tsang Wu Liu, MD +886-37-246166 ext 35120 firstname.lastname@example.org|
|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|
|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|