Optimizing Influenza Vaccination in Surgical Oncology Patients

This study is currently recruiting participants.
Verified April 2013 by Stony Brook University
Sponsor:
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT01698177
First received: August 11, 2011
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Influenza
Biological: Influenza vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Optimizing Influenza Vaccination in Surgical Oncology Patients

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Antibody Titer [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Serum antibody titers will be assessed prior to vaccination.

  • Antibody Titer [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Serum antibody titers will be assessed 2 weeks after vaccination

  • Antibody Titer [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Group A will have a late titer assessed, 4 weeks after vaccination


Secondary Outcome Measures:
  • Influenza-Like-Illness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    All subjects will be assessed for influenza-like-illness with a questionnaire 2 weeks after vaccination.

  • Surgical complications [ Time Frame: 30 days post op ] [ Designated as safety issue: No ]
    Any postoperative complications will be recorded, specifically wound infection, pneumonia, reintubation,sepsis, MI, PE,and anastomotic leak.


Estimated Enrollment: 204
Study Start Date: October 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698177

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

Locations
United States, New York
Stony Brook Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Colette R Pameijer, MD    631-444-8315    colette.pameijer@stonybrookmedicine.edu   
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Colette R Pameijer, MD Stony Brook University
  More Information

No publications provided

Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT01698177     History of Changes
Other Study ID Numbers: 240293
Study First Received: August 11, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
Influenza
Cancer
Vaccination
Immune response to influenza vaccination

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014