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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 353
- 试验地点
- 2
- 主要终点
- EBV reactivation rates between EGCG and placebo group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven NPC.
- •2010 AJCC stage II-IVB.
- •Age ≧ 20 years old.
- •Performance status of ECOG ≦
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo qd (2# bid) for 3 years
干预措施: Placebo (Dietary Supplement)
Epigallocatechin Gallate (EGCG)
EGCG 600 mg qd (2# bid) for 3 years
干预措施: Epigallocatechin Gallate (EGCG) (Other)
结局指标
主要结局
EBV reactivation rates between EGCG and placebo group
时间窗: 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.
次要结局
- Correlation between EBV reactivation and OS/RFS(q 3 months for first 3 years and q 6 months for the)