Optimizing Influenza Vaccination in Surgical Oncology Patients

Sponsor

Stony Brook University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01698177

Collaborator

(none)

204

Enrollment

Location

Arms

Duration (Months)

9.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Influenza vaccine Biological: Influenza vaccine	Phase 4

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Jul 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Influenza-Like-Illness [2 weeks]
All subjects will be assessed for influenza-like-illness with a questionnaire 2 weeks after vaccination.
Surgical complications [30 days post op]
Any postoperative complications will be recorded, specifically wound infection, pneumonia, reintubation,sepsis, MI, PE,and anastomotic leak.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.