Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

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
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Basic Science

Participation Requirements

Age
Between 35 years and 80 years
Gender
Only males

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 inflam...

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.

Tracking Information

NCT #
NCT02415387
Collaborators
Not Provided
Investigators
Principal Investigator: Janice Kiecolt-Glaser, PhD Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center