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Optimizing Influenza Vaccination in Surgical Oncology Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01698177
Recruitment Status : Unknown
Verified April 2013 by Stony Brook University.
Recruitment status was:  Recruiting
First Posted : October 2, 2012
Last Update Posted : April 19, 2013
Information provided by (Responsible Party):
Stony Brook University

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimizing Influenza Vaccination in Surgical Oncology Patients
Study Start Date : October 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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.

Primary Outcome Measures :
  1. Antibody Titer [ Time Frame: Baseline ]
    Serum antibody titers will be assessed prior to vaccination.

  2. Antibody Titer [ Time Frame: 2 weeks ]
    Serum antibody titers will be assessed 2 weeks after vaccination

  3. Antibody Titer [ Time Frame: 4 weeks ]
    Group A will have a late titer assessed, 4 weeks after vaccination

Secondary Outcome Measures :
  1. Influenza-Like-Illness [ Time Frame: 2 weeks ]
    All subjects will be assessed for influenza-like-illness with a questionnaire 2 weeks after vaccination.

  2. Surgical complications [ Time Frame: 30 days post op ]
    Any postoperative complications will be recorded, specifically wound infection, pneumonia, reintubation,sepsis, MI, PE,and anastomotic leak.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01698177

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Contact: Colette R Pameijer, MD 631-444-8315

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United States, New York
Stony Brook Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Colette R Pameijer, MD    631-444-8315   
Sponsors and Collaborators
Stony Brook University
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Principal Investigator: Colette R Pameijer, MD Stony Brook University

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Responsible Party: Stony Brook University Identifier: NCT01698177     History of Changes
Other Study ID Numbers: 240293
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Keywords provided by Stony Brook University:
Immune response to influenza vaccination
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs