Clinical trial NCT02213432: Influenza Vaccination in Cancer Patients
Official title: Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: influenza vaccine
cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Green Cross Corporation
First posted: 2014-08-11
Enrollment: 97
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 determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.

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 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group will get the vaccine at Day 11, 10 days after chemotherapy begins.

As the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group, we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.

Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days after vaccination) will be examined in all participants.

All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).

Eligibility criteria: 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.

Primary outcomes:
measure: Seroprotection rate
timeFrame: 21-28 days after vaccination
Secondary outcomes:
measure: Seroconversion factor
timeFrame: 21-28 days after vaccination
measure: Seroconversion rate
timeFrame: 21-28 days after vaccination
measure: Geometric mean titre of HI
timeFrame: 21-28 days after vaccination
measure: Vaccine-related adverse events
timeFrame: within 28 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Wan Beom Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: