Optimizing Influenza Vaccination in Surgical Oncology Patients

NCT ID: NCT01698177

Last Updated: 2013-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-07-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Group A

This group will receive the influenza vaccine preoperatively.

Group Type: ACTIVE_COMPARATOR

Influenza vaccine

Intervention Type: BIOLOGICAL

Seasonal inactivated trivalent vaccine

Group B

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

Group Type: ACTIVE_COMPARATOR

Influenza vaccine

Intervention Type: BIOLOGICAL

Seasonal inactivated trivalent vaccine

Group C

Group C subjects have already received the seasonal flu vaccine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group D

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Influenza vaccine

Seasonal inactivated trivalent vaccine

Intervention Type: BIOLOGICAL

Influenza vaccine

Seasonal inactivated trivalent vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colette R Pameijer, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook Hospital

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Colette R Pameijer, MD

Role: CONTACT

colette.pameijer@stonybrookmedicine.edu

631-444-8315

Facility Contacts

Colette R Pameijer, MD

Role: primary

colette.pameijer@stonybrookmedicine.edu

631-444-8315

References

Hirsch C, Zorger AM, Baumann M, Park YS, Brockelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N. Vaccines for preventing infections in adults with solid tumours. Cochrane Database Syst Rev. 2025 Apr 16;4(4):CD015551. doi: 10.1002/14651858.CD015551.pub2.

Reference Type: DERIVED

PMID: 40237463 (View on PubMed)

Other Identifiers

240293

Identifier Type: -

Identifier Source: org_study_id