Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer
IMPACT
The IMPACT Study: Inflammatory Responses, Mood and Physical Fitness After Cancer Treatment
2 other identifiers
interventional
172
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jan 2014
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2021
CompletedResults Posted
Study results publicly available
July 24, 2024
CompletedJuly 24, 2024
July 1, 2024
7.3 years
April 9, 2015
June 6, 2022
July 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
AUC Change in Level of IL-6
AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.
Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine
Secondary Outcomes (2)
AUC Change in Pain
baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine
AUC Change in Fatigue
baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine
Study Arms (2)
Arm I (inactive typhoid vaccine, placebo)
EXPERIMENTALPatients receive inactive typhoid vaccine IM at visit 1 followed by placebo IM 30 days later at visit 2.
Arm II (placebo, inactive typhoid vaccine)
PLACEBO COMPARATORPatients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.
Interventions
Given IM
Given IM
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Women who have received a typhoid vaccine within the last three years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Related Publications (1)
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.
PMID: 36943254DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Our study focused on the initial, rapid inflammatory response, and we did not assess antibody responses to the vaccine, one limitation.
Results Point of Contact
- Title
- Juan Peng
- Organization
- Center for Biostatistics, The Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Janice Kiecolt-Glaser, PhD
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 9, 2015
First Posted
April 14, 2015
Study Start
January 1, 2014
Primary Completion
April 27, 2021
Study Completion
April 27, 2021
Last Updated
July 24, 2024
Results First Posted
July 24, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share