Early Phase 1
N=172
Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer
Cognitive Side Effects of Cancer Therapy · Depression · Recurrent Breast Carcinoma · Stage IA Breast Cancer · Stage IB Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02415387 ↗Enrolled (actual)
172
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: AUC Change in Level of IL-6 — 5.23; 10.17 ug*hour/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- typhoid vaccine (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC Change in Level of IL-6 |
5.23; 10.17 | — |
| SECONDARY AUC Change in Pain |
1.06; 3.24 | — |
| SECONDARY AUC Change in Fatigue |
4.05; 3.62 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02415387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.