Clinical trial · Interventional
Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors
Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)
NCT04088708CI-TRIAL-00095215ROMEactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Exercise | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Gut Microbiome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic Exercise Training | Other | — | UNRESOLVED |
| Attention Control | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aerobic Exercise Training
- description
- Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.
- interventionNames
- Other: Aerobic Exercise Training
- type
- ACTIVE_COMPARATOR
- label
- Attention Control
- description
- The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.
- interventionNames
- Other: Attention Control
Primary outcomes (4)
- measure
- Composition of gut microbiota as measured by fecal samples
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLittle RB, Carter SJ, Motl RW, Hunter G, Cook A, Liu N, Krontiras H, Lefkowitz EJ, Turan B, Schleicher E, Rogers LQ. Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial. BMJ Open. 2024 May 3;14(5):e081660. doi: 10.1136/bmjopen-2023-081660. PMID 38702085