Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer

NCT ID: NCT02415387

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2021-04-27

Brief Summary

This randomized clinical trial uses an inactive typhoid vaccine to briefly stimulate an immune response in patients with stage I-IIIA breast cancer who received primary cancer treatment and studies whether patients' fitness levels affect how their bodies handle a challenge to their immune system. A vaccine is a substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms such as bacteria or viruses. Immune responses may cause excess inflammation in the body and behavioral changes, such as depression, fatigue, pain, and problems with thinking and reasoning. Studying immune responses in patients with breast cancer who have undergone primary cancer treatment may help doctors learn whether physical fitness can protect the body from effects of immune system stress and whether it may be able to reduce health problems in patients with breast cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the relationships between cardiorespiratory fitness and inflammatory and behavioral responses (negative mood, fatigue, pain, and cognitive problems) to typhoid vaccine in breast cancer survivors.

II. To determine the effects of age and depressive symptoms on inflammatory and behavioral responses to typhoid vaccine and placebo.

III. To assess the ability of cardiorespiratory fitness to moderate age- and depression-related responses to typhoid vaccine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive inactive typhoid vaccine intramuscularly (IM) at visit 1 followed by placebo IM 30 days later at visit 2.

ARM II: Patients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.

There is an initial screening visit where patients in both arms complete an audio-recorded interview that includes questions about changes in mood and emotion throughout their lives, body measurements, a finger stick to assess for anemia and diabetes markers. During visit 1 and 2, patients in both arms will have blood drawn periodically and complete sets of questionnaires that assess feelings, health behaviors, and personality. Patients also complete cognitive tasks and a temperature sensitivity task at 3-4.5 hours post-injection.

Conditions

Cognitive Side Effects of Cancer Therapy; Depression; Recurrent Breast Carcinoma; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Arm I (inactive typhoid vaccine, placebo)

Patients receive inactive typhoid vaccine IM at visit 1 followed by placebo IM 30 days later at visit 2.

Group Type: EXPERIMENTAL

typhoid vaccine

Intervention Type: BIOLOGICAL

Given IM

Placebo

Intervention Type: OTHER

Given IM

Arm II (placebo, inactive typhoid vaccine)

Patients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.

Group Type: PLACEBO_COMPARATOR

typhoid vaccine

Intervention Type: BIOLOGICAL

Given IM

Placebo

Intervention Type: OTHER

Given IM

Interventions

typhoid vaccine

Given IM

Intervention Type: BIOLOGICAL

Placebo

Given IM

Intervention Type: OTHER

Other Intervention Names

PLCB

Eligibility Criteria

Inclusion Criteria

• Women who have been diagnosed with stage I-IIIA breast cancer will be recruited 1-10 years after the completion of all primary cancer treatment except for longer-term hormonal therapies (tamoxifen, aromatase inhibitors)
• All women will be postmenopausal

Exclusion Criteria

• A prior history of any other malignancy except basal or squamous cell skin cancers, strokes, diabetes, current heart disease or uncontrolled hypertension, peripheral vascular disease, liver disease, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, and other medical conditions that would limit participation in the assessments (e.g., pulmonary disease, orthopedic problems, major psychiatric illness, major cognitive dysfunction, or an acute medical problem)
• Anemia
• Alcohol or drug abuse
• Smoking
• Medication exclusions will include steroids as well as statins and other medications with anti-inflammatory actions
• Women who have received a typhoid vaccine within the last three years

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Janice Kiecolt-Glaser

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janice Kiecolt-Glaser, PhD

Role: PRINCIPAL_INVESTIGATOR

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center

Locations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

References

Madison AA, Renna M, Andridge R, Peng J, Shrout MR, Sheridan J, Lustberg M, Ramaswamy B, Wesolowski R, Williams NO, Noonan AM, Reinbolt RE, Stover DG, Cherian MA, Malarkey WB, Kiecolt-Glaser JK. Conflicts hurt: social stress predicts elevated pain and sadness after mild inflammatory increases. Pain. 2023 Sep 1;164(9):1985-1994. doi: 10.1097/j.pain.0000000000002894. Epub 2023 Mar 22.

Reference Type: DERIVED

PMID: 36943254 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2014-01251

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-13194

Identifier Type: -

Identifier Source: org_study_id