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Optimizing Influenza Vaccination in Surgical Oncology Patients

Primary Purpose

Influenza

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Influenza vaccine
Influenza vaccine
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza focused on measuring Influenza, Cancer, Vaccination, Immune response to influenza vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

  • Stony Brook HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

No Intervention

Placebo Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

This group will receive the influenza vaccine preoperatively.

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

Group C subjects have already received the seasonal flu vaccine.

Group D subjects have refused the vaccine, but agree to have serum titers drawn.

Outcomes

Primary Outcome Measures

Antibody Titer
Serum antibody titers will be assessed prior to vaccination.
Antibody Titer
Serum antibody titers will be assessed 2 weeks after vaccination
Antibody Titer
Group A will have a late titer assessed, 4 weeks after vaccination

Secondary Outcome Measures

Influenza-Like-Illness
All subjects will be assessed for influenza-like-illness with a questionnaire 2 weeks after vaccination.
Surgical complications
Any postoperative complications will be recorded, specifically wound infection, pneumonia, reintubation,sepsis, MI, PE,and anastomotic leak.

Full Information

First Posted
August 11, 2011
Last Updated
April 18, 2013
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT01698177
Brief Title
Optimizing Influenza Vaccination in Surgical Oncology Patients
Official Title
Optimizing Influenza Vaccination in Surgical Oncology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Cancer, Vaccination, Immune response to influenza vaccination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
This group will receive the influenza vaccine preoperatively.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B will receive the influenza vaccine postoperatively, prior to hospital discharge.
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Group C subjects have already received the seasonal flu vaccine.
Arm Title
Group D
Arm Type
Placebo Comparator
Arm Description
Group D subjects have refused the vaccine, but agree to have serum titers drawn.
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Intervention Description
Seasonal inactivated trivalent vaccine
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Intervention Description
Seasonal inactivated trivalent vaccine
Primary Outcome Measure Information:
Title
Antibody Titer
Description
Serum antibody titers will be assessed prior to vaccination.
Time Frame
Baseline
Title
Antibody Titer
Description
Serum antibody titers will be assessed 2 weeks after vaccination
Time Frame
2 weeks
Title
Antibody Titer
Description
Group A will have a late titer assessed, 4 weeks after vaccination
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Influenza-Like-Illness
Description
All subjects will be assessed for influenza-like-illness with a questionnaire 2 weeks after vaccination.
Time Frame
2 weeks
Title
Surgical complications
Description
Any postoperative complications will be recorded, specifically wound infection, pneumonia, reintubation,sepsis, MI, PE,and anastomotic leak.
Time Frame
30 days post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. - 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colette R Pameijer, MD
Phone
631-444-8315
Email
colette.pameijer@stonybrookmedicine.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colette R Pameijer, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colette R Pameijer, MD
Phone
631-444-8315
Email
colette.pameijer@stonybrookmedicine.edu

12. IPD Sharing Statement

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Optimizing Influenza Vaccination in Surgical Oncology Patients

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