Optimizing Influenza Vaccination in Surgical Oncology Patients

Condition(s) targeted: Influenza

Intervention: Influenza vaccine (Biological); Influenza vaccine (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: Stony Brook University

Official(s) and/or principal investigator(s):
Colette R Pameijer, MD, Principal Investigator, Affiliation: Stony Brook University

Overall contact:
Colette R Pameijer, MD, Phone: 631-444-8315, Email: colette.pameijer@stonybrookmedicine.edu

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: Optimizing Influenza Vaccination in Surgical Oncology Patients

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome:

Antibody Titer

Antibody Titer

Antibody Titer

Secondary outcome:

Influenza-Like-Illness

Surgical complications

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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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Colette R Pameijer, MD, Phone: 631-444-8315, Email: colette.pameijer@stonybrookmedicine.edu

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

Starting date: October 2011
Last updated: April 18, 2013