This randomized clinical trial uses a typhoid vaccine to cause an immune response in patients with stage I-IIIA breast cancer who received chemotherapy and studies whether patients' fitness levels affect how well 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 chemotherapy 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 who have undergone chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02415387.
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.
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 typhoid vaccine intramuscularly (IM) at visit 1 followed by placebo IM 14-30 days later at visit 2.
ARM II: Patients receive placebo IM at visit 1 followed by typhoid vaccine IM 14-30 days later at visit 2.
During each visit, patients in both arms complete an audio-recorded questionnaire that includes questions about mood, feelings, health behaviors, health, and personality. Patients also complete cognitive tasks at 3-4.5 hours post-injection and receive a cold tolerance test following the post-injection assessment.
Trial PhaseNo phase specified
Trial Typebasic science
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorJanice Kiecolt-Glaser