Effects of exercise on gut bacteria in breast cancer survivors
Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)
NA · University of Alabama at Birmingham · NCT04088708
This study is testing how exercise affects gut bacteria in breast cancer survivors to see if it can help reduce fatigue and improve their overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04088708 on ClinicalTrials.gov |
What this trial studies
This project aims to explore how exercise influences the gut microbiome in breast cancer survivors and its relationship with psychosocial symptoms like fatigue. The study will implement a controlled-feeding diet alongside 10 weeks of aerobic exercise training to assess changes in gut bacteria composition. By linking these microbiome changes to fatigue and physiological responses to exercise, the research seeks to enhance the benefits of exercise and identify new treatment strategies for improving health outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 to 74 with a history of breast cancer who are at least one year post-treatment and experience clinically meaningful fatigue.
Not a fit: Patients with metastatic or recurrent cancer or those with other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of fatigue and overall health in breast cancer survivors through tailored exercise interventions.
How similar studies have performed: Other studies have shown promising results in the relationship between exercise and gut microbiome health, suggesting this approach may yield beneficial outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * BMI \>50 * Anticipate needing antibiotics during the study period
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Principal investigator: Laura Q Rogers, MD, MPH — University of Alabama at Birmingham
- Study coordinator: Laura Q Rogers, MD, MPH
- Email: rogersl@uab.edu
- Phone: (205) - 934 - 9735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Gut Microbiome, Exercise, Fatigue, breast cancer, fatigue, exercise, psychosocial outcomes