Clinical trial · Interventional
Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer
The IMPACT Study: Inflammatory Responses, Mood and Physical Fitness After Cancer Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Side Effects of Cancer Therapy | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Recurrent Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| typhoid vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (inactive typhoid vaccine, placebo)
- description
- Patients receive inactive typhoid vaccine IM at visit 1 followed by placebo IM 30 days later at visit 2.
- interventionNames
- Biological: typhoid vaccine
- Other: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo, inactive typhoid vaccine)
- description
- Patients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.
- interventionNames
- Biological: typhoid vaccine
- Other: Placebo
Primary outcomes (1)
- measure
- AUC Change in Level of IL-6
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMadison 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 36943254