Recruiting

Influenza Vaccination

Sponsor:

Stony Brook University

Code:

NCT01698177

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Influenza vaccine

Influenza vaccine

Study Details

Brief summary:

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.

Conditions

Influenza

Study ID

NCT01698177

Start date

Oct, 2011

Status verified date

Apr, 2013

Completion date

Jul, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Group A

This group will receive the influenza vaccine preoperatively.

active comparator: Group B

Group B will receive the influenza vaccine postoperatively, prior to hospital discharge.

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.

Interventions

Influenza vaccine

Seasonal inactivated trivalent vaccine

Influenza vaccine

Seasonal inactivated trivalent vaccine

Primary outcome measure

  • Antibody Titer [ Time Frame: Baseline ]
  • Antibody Titer [ Time Frame: 2 weeks ]
  • Antibody Titer [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Stony Brook Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

More Information

Sponsor

Stony Brook University

Last update posted

Apr 19, 2013

Last verified

Apr, 2013

Keywords

  • Influenza
  • Cancer
  • Vaccination
  • Immune response to influenza vaccination

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2013-04-19.