Optimizing Influenza Vaccination in Surgical Oncology Patients

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.

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Biological: Influenza vaccine

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Colette R Pameijer, MD; Phone Number: 631-444-8315; Email: colette.pameijer@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook Hospital
      • Contact: Colette R Pameijer, MD; Phone Number: 631-444-8315; Email: colette.pameijer@stonybrookmedicine.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:Patients with gastric or pancreatic cancer, soft tissue sarcoma or peritoneal surface malignancy who will undergo surgery with curative intent are eligible.

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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.

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Colette R Pameijer, MD, Stony Brook University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): April 19, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Cancer; Influenza; Vaccination; Immune response to influenza vaccination
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 240293