<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01698177</url>
  </required_header>
  <id_info>
    <org_study_id>240293</org_study_id>
    <nct_id>NCT01698177</nct_id>
  </id_info>
  <brief_title>Optimizing Influenza Vaccination in Surgical Oncology Patients</brief_title>
  <official_title>Optimizing Influenza Vaccination in Surgical Oncology Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Seasonal influenza (flu) is a significant and sometimes serious health issue in the U.S. The&#xD;
      Centers for Disease Control (CDC) estimates that over 200,000 people are hospitalized in the&#xD;
      U.S each year related to the flu. Public health campaigns advocate widespread vaccination for&#xD;
      the flu, and especially for high risk people. People with cancer are high risk, with an&#xD;
      increased risk of developing complications from the flu, such as pneumonia, bronchitis, or&#xD;
      worsening of other medical conditions. As part of their vaccination campaign, the CDC&#xD;
      strongly encourages inpatients to be vaccinated prior to hospital discharge. Accordingly,&#xD;
      Stony Brook Hospital has enacted a policy that mandates screening all hospital inpatients for&#xD;
      vaccination prior to discharge. While physicians or patients can opt not to vaccinate, the&#xD;
      default is to proceed. Surgical oncologists have several concerns about vaccinating their&#xD;
      patients after major surgical procedures. Patients with cancer have impaired immunity, and&#xD;
      the ability of our patients to mount an effective immune response to the vaccine is unclear.&#xD;
      Conversely, due to their immunocompromised state, our patients may be more susceptible to&#xD;
      complications from the vaccine, such as influenza-like-illness (ILI), or have higher rates of&#xD;
      postoperative complications due to the additional immune challenge of the vaccine. Previous&#xD;
      studies have evaluated the flu vaccine in patients receiving chemotherapy, or after organ&#xD;
      transplantation, but the combination of cancer and major surgery remains unstudied.&#xD;
&#xD;
      This is a collaborative study with Infectious Diseases and Microbiology to evaluate the&#xD;
      response to the flu vaccine in patients with pancreatic or gastric cancer, soft tissue&#xD;
      sarcoma or peritoneal surface disease (i.e. carcinomatosis from appendiceal or colon&#xD;
      cancers). Patients will be randomly selected to receive the vaccine either 2 weeks&#xD;
      preoperatively or postoperatively at the time of discharge. Serum antibody response, rates of&#xD;
      ILI and post-op complications will be analyzed. The long term goal of this study is two-fold:&#xD;
      to determine the optimal time to vaccinate this group of patients in relation to their&#xD;
      surgery, and to improve compliance with vaccination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Antibody Titer</measure>
    <time_frame>Baseline</time_frame>
    <description>Serum antibody titers will be assessed prior to vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antibody Titer</measure>
    <time_frame>2 weeks</time_frame>
    <description>Serum antibody titers will be assessed 2 weeks after vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antibody Titer</measure>
    <time_frame>4 weeks</time_frame>
    <description>Group A will have a late titer assessed, 4 weeks after vaccination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influenza-Like-Illness</measure>
    <time_frame>2 weeks</time_frame>
    <description>All subjects will be assessed for influenza-like-illness with a questionnaire 2 weeks after vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical complications</measure>
    <time_frame>30 days post op</time_frame>
    <description>Any postoperative complications will be recorded, specifically wound infection, pneumonia, reintubation,sepsis, MI, PE,and anastomotic leak.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">204</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive the influenza vaccine preoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group B will receive the influenza vaccine postoperatively, prior to hospital discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group C subjects have already received the seasonal flu vaccine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group D subjects have refused the vaccine, but agree to have serum titers drawn.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza vaccine</intervention_name>
    <description>Seasonal inactivated trivalent vaccine</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza vaccine</intervention_name>
    <description>Seasonal inactivated trivalent vaccine</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Patients with gastric or pancreatic cancer, soft tissue sarcoma or&#xD;
        peritoneal surface malignancy who will undergo surgery with curative intent are eligible.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:Those with a contraindication to vaccination, patients who have a&#xD;
        splenectomy (whether planned or not) and those who have had the flu for the year are not&#xD;
        eligible.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colette R Pameijer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stony Brook University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Colette R Pameijer, MD</last_name>
    <phone>631-444-8315</phone>
    <email>colette.pameijer@stonybrookmedicine.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stony Brook Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colette R Pameijer, MD</last_name>
      <phone>631-444-8315</phone>
      <email>colette.pameijer@stonybrookmedicine.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>August 11, 2011</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>April 18, 2013</last_update_submitted>
  <last_update_submitted_qc>April 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Cancer</keyword>
  <keyword>Vaccination</keyword>
  <keyword>Immune response to influenza vaccination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698177
org study id: 240293
nct id: NCT01698177
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Antibody Titer
time frame: Baseline
description: Serum antibody titers will be assessed prior to vaccination.
measure: Antibody Titer
time frame: 2 weeks
description: Serum antibody titers will be assessed 2 weeks after vaccination
measure: Antibody Titer
time frame: 4 weeks
description: Group A will have a late titer assessed, 4 weeks after vaccination
measure: Influenza-Like-Illness
time frame: 2 weeks
description: All subjects will be assessed for influenza-like-illness with a questionnaire 2 weeks after vaccination.
measure: Surgical complications
time frame: 30 days post op
description: Any postoperative complications will be recorded, specifically wound infection, pneumonia, reintubation,sepsis, MI, PE,and anastomotic leak.
arm group label: Group A
arm group type: Active Comparator
description: This group will receive the influenza vaccine preoperatively.
arm group label: Group B
arm group type: Active Comparator
description: Group B will receive the influenza vaccine postoperatively, prior to hospital discharge.
arm group label: Group C
arm group type: No Intervention
description: Group C subjects have already received the seasonal flu vaccine.
arm group label: Group D
arm group type: Placebo Comparator
description: Group D subjects have refused the vaccine, but agree to have serum titers drawn.
intervention type: Biological
intervention name: Influenza vaccine
description: Seasonal inactivated trivalent vaccine
arm group label: Group A
intervention type: Biological
intervention name: Influenza vaccine
description: Seasonal inactivated trivalent vaccine
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Colette R Pameijer, MD
role: Principal Investigator
affiliation: Stony Brook University
last name: Colette R Pameijer, MD
phone: 631-444-8315
email: colette.pameijer@stonybrookmedicine.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines