Optimizing Influenza Vaccination in Surgical Oncology Patients

Influenza Clinical Trial

Official title:

Optimizing Influenza Vaccination in Surgical Oncology Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01698177
• Other study ID #: 240293
• Status: Recruiting
• Phase: Phase 4
• First received: August 11, 2011
• Last updated: April 18, 2013
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: April 2013
• Source: Stony Brook University
• Contact: Colette R Pameijer, MD
• Phone: 631-444-8315
• Email: colette.pameijer[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza vaccine
Seasonal inactivated trivalent vaccine
• Influenza vaccine
Seasonal inactivated trivalent vaccine

Locations

Country	Name	City	State
United States	Stony Brook Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody Titer	Serum antibody titers will be assessed prior to vaccination.	Baseline	No
Primary	Antibody Titer	Serum antibody titers will be assessed 2 weeks after vaccination	2 weeks	No
Primary	Antibody Titer	Group A will have a late titer assessed, 4 weeks after vaccination	4 weeks	No
Secondary	Influenza-Like-Illness	All subjects will be assessed for influenza-like-illness with a questionnaire 2 weeks after vaccination.	2 weeks	No
Secondary	Surgical complications	Any postoperative complications will be recorded, specifically wound infection, pneumonia, reintubation,sepsis, MI, PE,and anastomotic leak.	30 days post op	No