Status:
TERMINATED
Influenza Vaccination in Cancer Patients
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Green Cross Corporation
Conditions:
Cancer
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemo...
Detailed Description
The participants will be stratified by the age (cut off; 60 years old) and last year influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11 vaccination group. Day...
Eligibility Criteria
Inclusion
- Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer.
- Specific definition of each term is like following:
- The solid cancer includes various kinds of cancer except hematologic and lymphoid malignancies.
- Cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of chemotherapy with the planned duration at least over 3 cycles every 3 weeks.
- Targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or oral chemotherapy drugs like as Xeloda are excluded.
- Patients who did not receive the influenza vaccination yet in the current year.
- Older than 19 years
- Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2
- Cell blood count meets following criteria:
- Neutrophile count ≥ 1.5 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Hemoglobin ≥ 8 g/dL
- Patients who can understand and agreed with the informed consents.
Exclusion
- Patients who have any contraindication for influenza vaccination.
- Patients who are supposed to receive the last chemotherapy at the enrollment
- Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy
- Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
- Patients with HIV and low CD 4+ T cell count (\< 500/uL)
- Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
- Patients who have transplanted organ and receive immunosuppressants
- Patients who are supposed to get prophylactic G-CSF after chemotherapy
- Patients who are suspected to have active infectious disease.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT02213432
Start Date
September 1 2014
End Date
August 1 2015
Last Update
February 24 2016
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea