Exercise Program in Cancer and Cognition
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This randomized control trial will examine whether a well-controlled and monitored exercise
      intervention improves cognitive function in postmenopausal women with early-stage breast
      cancer and will explore whether neuroimaging metrics of brain health, pro-inflammatory
      biomarkers and symptoms (fatigue, sleep problems, depression, anxiety) mediate the effects of
      exercise on cognitive function. Furthermore, the study will explore whether the magnitude of
      the improvements in cognitive function are modified by estradiol levels.
    

Detailed description: 
      The specific aims include:

        1. Compared to usual care, examine whether the 6-month exercise intervention improves
           cognitive function in postmenopausal women with early stage breast cancer.

           Hypothesis 1. Exercise will improve cognitive function in women in a domain specific
           fashion such that attention, executive and memory functions will be influenced more than
           other domains.

        2. Compared to usual care, examine the direct effects of exercise on neuroimaging metrics
           of brain health including regional gray matter volume, white matter architecture and
           functional dynamics of the brain and the pro-inflammatory biomarkers (IL-6 as primary
           outcomes; TNF-α as secondary), and explore the direct effects of exercise on symptoms
           (fatigue, sleep problems, depression, anxiety).

           Hypothesis 2. Exercise will improve neuroimaging metrics of brain health and
           pro-inflammatory biomarkers.

        3. Compared to usual care, explore whether the effects of exercise on cognitive function
           are mediated by a) neuroimaging metrics of cognitive function, b) IL-6 and TNF-α levels
           and c) symptoms (fatigue, sleep problems, depression, anxiety), and moderated by E2
           levels.
    

Intervention name(s): Moderate-Intensity Aerobic Exercise Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Alteration; Cognitive Function; Exercise