Influenza Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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