Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Composition of gut microbiota as measured by fecal samples
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.
Detailed Description
Cancer survivors are at increased risk of gut bacteria communities that can negatively impact health and energy level and it is possible that exercise can cause healthy changes in these communities. Through careful design, this study will use a controlled-feeding diet and 10 weeks of exercise training to determine exercise effects on the number, distribution, and types of bacteria in the gut of breast cancer survivors. These changes will then be linked to fatigue and physiologic effects of exercise to determine how the information can be used to enhance exercise benefits and identify new treatment strategies leveraging changes in gut bacteria communities.
Investigators
Laura Q. Rogers, MD, MPH
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Composition of gut microbiota as measured by fecal samples
Time Frame: 15 weeks after baseline
Using standard diversity and taxa comparison metrics
Secondary Outcomes
- Autonomic nervous system measured through non-invasive ECG(15 weeks after baseline)
- Systemic inflammation tested via biomarkers(10 weeks after baseline)
- Systemic inflammation tested via blood biomarkers(15 weeks after baseline)
- Concentration of cortisol measured through hair sample(15 weeks after baseline)
- Fatigue measured through fatigue specific questionnaire(15 weeks after baseline)