Optimizing Influenza Vaccination in Surgical Oncology Patients

Study Overview
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Brief Summary
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Seasonal influenza (flu) is a significant and sometimes serious health issue in the U.S. The Centers for Disease Control (CDC) estimates that over 200,000 people are hospitalized in the U.S each year related to the flu. Public health campaigns advocate widespread vaccination for the flu, and especially for high risk people. People with cancer are high risk, with an increased risk of developing complications from the flu, such as pneumonia, bronchitis, or worsening of other medical conditions. As part of their vaccination campaign, the CDC strongly encourages inpatients to be vaccinated prior to hospital discharge. Accordingly, Stony Brook Hospital has enacted a policy that mandates screening all hospital inpatients for vaccination prior to discharge. While physicians or patients can opt not to vaccinate, the default is to proceed. Surgical oncologists have several concerns about vaccinating their patients after major surgical procedures. Patients with cancer have impaired immunity, and the ability of our patients to mount an effective immune response to the vaccine is unclear. Conversely, due to their immunocompromised state, our patients may be more susceptible to complications from the vaccine, such as influenza-like-illness (ILI), or have higher rates of postoperative complications due to the additional immune challenge of the vaccine. Previous studies have evaluated the flu vaccine in patients receiving chemotherapy, or after organ transplantation, but the combination of cancer and major surgery remains unstudied. This is a collaborative study with Infectious Diseases and Microbiology to evaluate the response to the flu vaccine in patients with pancreatic or gastric cancer, soft tissue sarcoma or peritoneal surface disease (i.e. carcinomatosis from appendiceal or colon cancers). Patients will be randomly selected to receive the vaccine either 2 weeks preoperatively or postoperatively at the time of discharge. Serum antibody response, rates of ILI and post-op complications will be analyzed. The long term goal of this study is two-fold: to determine the optimal time to vaccinate this group of patients in relation to their surgery, and to improve compliance with vaccination.

Official Title
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Optimizing Influenza Vaccination in Surgical Oncology Patients

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza vaccine
* Biological: Influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Patients with gastric or pancreatic cancer, soft tissue sarcoma or peritoneal surface malignancy who will undergo surgery with curative intent are eligible. - Exclusion Criteria:Those with a contraindication to vaccination, patients who have a splenectomy (whether planned or not) and those who have had the flu for the year are not eligible. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>This group will receive the influenza vaccine preoperatively. | Biological: Influenza vaccine<br>* Seasonal inactivated trivalent vaccine<br>|
| Active Comparator: Group B<br>Group B will receive the influenza vaccine postoperatively, prior to hospital discharge. | Biological: Influenza vaccine<br>* Seasonal inactivated trivalent vaccine<br>|
| No Intervention: Group C<br>Group C subjects have already received the seasonal flu vaccine. | |
| Placebo Comparator: Group D<br>Group D subjects have refused the vaccine, but agree to have serum titers drawn. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Titer | Serum antibody titers will be assessed prior to vaccination. | Baseline | 
| Antibody Titer | Serum antibody titers will be assessed 2 weeks after vaccination | 2 weeks | 
| Antibody Titer | Group A will have a late titer assessed, 4 weeks after vaccination | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza-Like-Illness | All subjects will be assessed for influenza-like-illness with a questionnaire 2 weeks after vaccination. | 2 weeks | 
| Surgical complications | Any postoperative complications will be recorded, specifically wound infection, pneumonia, reintubation,sepsis, MI, PE,and anastomotic leak. | 30 days post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Cancer, Vaccination, Immune response to influenza vaccination