Clinical trial NCT01744587: Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients
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
Overall status: UNKNOWN
Phase: NA
Conditions: NPC
Keywords: EBV
EGCG
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: Mackay Memorial Hospital
name: Taichung Veterans General Hospital
name: National Cheng-Kung University Hospital
name: Chang Gung Memorial Hospital
name: China Medical University Hospital
name: National Taiwan University Hospital
First posted: 2012-12-06
Enrollment: 353
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: EBV reactivation rates between EGCG and placebo group
timeFrame: every 3 months for the first 3 years and every 6 months thereafter for antibodies tests and pEBV DNA assay (total 5 years)
Secondary outcomes:
measure: Correlation between EBV reactivation and OS/RFS
timeFrame: q 3 months for first 3 years and q 6 months for the
Other outcomes:
Locations:
city: Zhunan
country: Taiwan
facility: Taiwan Cooperative Oncology Group, National Health Research Institutes
state: Miaoli
Study officials:
affiliation: Taiwan Cooperative Oncology Group, National Health Research Institutes
name: Tsang Wu Liu, MD
role: STUDY_DIRECTOR
affiliation: Taichung Veterans General Hospital
name: Jin Ch Lin, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cancer Research, National Health Research Institutes
name: Jen Ya Chen, PHD
role: PRINCIPAL_INVESTIGATOR
References: