Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Composition of gut microbiota as measured by fecal samples
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Assessors will be blinded to participant study group allocation
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women ages 18 to 74 years with a history of breast cancer stage 0, I, II, or III,
- •≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation),
- •Average fatigue over the past week rated as ≥3 on a 1 to 10 Likert scale, cut point chosen because it is a clinically meaningful cutpoint,93
- •English speaking,
- •Physician medical clearance for study participation,
- •Able to ambulate without assistance,
- •No antibiotics for the past 90 days,
- •Willing to avoid taking probiotics for the duration of the study
- •Peak VO2 <30 ml/kg/min (note: will measure peak VO2 if the participant meets all other criteria and consents to lab-based screening).
Exclusion Criteria
- •Metastatic or recurrent cancer
- •Another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ), 3)
- •Unstable angina
- •New York Heart Association class II, III, or IV congestive heart failure
- •Uncontrolled asthma
- •Interstitial lung disease
- •Current steroid use
- •Having been told by a physician to only do exercise prescribed by a physician
- •Dementia or organic brain syndrome
- •Schizophrenia or active psychosis
- •Connective tissue or rheumatologic disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, CREST syndrome, polymyositis, dermatomyositis, progressive systemic sclerosis, vasculitis, polymyalgia rheumatic, temporal arteritis)
- •Anticipate elective surgery during the study period
- •Anticipate changes in usual medications during the study period
- •Plan to move residence out of the local area during the study period
- •Plan to travel out of the local area for >1 week during study participation
- •Contraindication to engaging in moderate-to-vigorous intensity aerobic exercise
- •Currently pregnant or anticipate pregnancy during study participation
- •Live or work >50 miles from study site or do not have transportation to study site
- •Anticipate needing antibiotics during the study period
Arms & Interventions
Aerobic Exercise Training
Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
Intervention: Aerobic Exercise Training (Other)
Attention Control
The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.
Intervention: Attention Control (Other)
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
Composition of gut microbiota as measured by fecal samples
Time Frame: Baseline
Using standard diversity and taxa comparison metrics
Composition of gut microbiota as measured by fecal samples
Time Frame: 5 weeks after baseline
Using standard diversity and taxa comparison metrics
Composition of gut microbiota as measured by fecal samples
Time Frame: 10 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)
- Systemic inflammation tested via blood biomarkers(5 weeks after baseline)
- Systemic inflammation tested via blood biomarkers(Baseline)
- Concentration of cortisol measured through hair sample(10 weeks after baseline)
- Autonomic nervous system measured through non-invasive ECG(Baseline)
- Autonomic nervous system measured through non-invasive ECG(5 weeks after baseline)
- Autonomic nervous system measured through non-invasive ECG(10 weeks after baseline)
- Concentration of cortisol measured through hair sample(Baseline)
- Concentration of cortisol measured through hair sample(5 weeks after baseline)
- Fatigue measured through fatigue specific questionnaire(Baseline)
- Fatigue measured through fatigue specific questionnaire(5 weeks after baseline)
- Fatigue measured through fatigue specific questionnaire(10 weeks after baseline)
Investigators
Laura Q. Rogers, MD, MPH
Principal Investigator
University of Alabama at Birmingham