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Group B for Influenza

Phase 4
Waitlist Available
Led By Colette R Pameijer, MD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post op
Awards & highlights

Study 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.

Eligible Conditions
  • Influenza

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibody Titer
Secondary outcome measures
Influenza-Like-Illness
Surgical complications

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Group BActive Control1 Intervention
Group B will receive the influenza vaccine postoperatively, prior to hospital discharge.
Group II: Group CActive Control1 Intervention
Group C subjects have already received the seasonal flu vaccine.
Group III: Group AActive Control1 Intervention
This group will receive the influenza vaccine preoperatively.
Group IV: Group DPlacebo Group1 Intervention
Group D subjects have refused the vaccine, but agree to have serum titers drawn.

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
215 Previous Clinical Trials
39,723 Total Patients Enrolled
Colette R Pameijer, MDPrincipal InvestigatorStony Brook University
1 Previous Clinical Trials
12 Total Patients Enrolled

Frequently Asked Questions

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~15 spots leftby Apr 2025