Clinical trial · Interventional
Influenza Vaccination in Cancer Patients
Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy
NCT02213432CI-TRIAL-00021076terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient enrollment
Summary
Brief summary (as posted)
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 chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Different timing of influenza vaccination | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Day 1 vaccination
- description
- Different timing of influenza vaccination: Day 1 Day 1 vaccination group: patients will be vaccinated against influenza at the day (Day 1) when chemotherapy starts.
- interventionNames
- Biological: Different timing of influenza vaccination
- type
- ACTIVE_COMPARATOR
- label
- Day 11 vaccination
- description
- Different timing of influenza vaccination: Day 11 Day 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts
- interventionNames
- Biological: Different timing of influenza vaccination
Primary outcomes (1)
- measure
- Seroprotection rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Patients who did not receive the influenza vaccination yet in the current year. 3. Older than 19 years 4. Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2 5. 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 6. Patients who can understand and agreed with the informed consents. Exclusion Criteria: 1. Patients who have any contraindication for influenza vaccination. 2. Patients who are supposed to receive the last chemotherapy at the enrollment 3. Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy 4. Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect) 5. Patients with HIV and low CD 4+ T cell count (\< 500/uL) 6. Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine 7. Patients who have transplanted organ and receive immunosuppressants 8. Patients who are supposed to get prophylactic G-CSF after chemotherapy 9. Patients who are suspected to have active infectious disease.
References
Publications (0)
Data not yet available
No reference posted for this study.