Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

NCT04088708 | Active Not Recruiting DMC

• 2 other identifiers: IRB-30000320R01CA235598
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Gut Microbiome; Exercise; Fatigue

Keywords

breast cancer; fatigue; exercise; psychosocial outcomes; inflammation; gut microbiome

Outcome Measures

Primary Outcomes (4)

• Composition of gut microbiota as measured by fecal samples

  Using standard diversity and taxa comparison metrics

  Baseline

• Composition of gut microbiota as measured by fecal samples

  Using standard diversity and taxa comparison metrics

  5 weeks after baseline

• Composition of gut microbiota as measured by fecal samples

  Using standard diversity and taxa comparison metrics

  10 weeks after baseline

• Composition of gut microbiota as measured by fecal samples

  Using standard diversity and taxa comparison metrics

  15 weeks after baseline

Secondary Outcomes (16)

• Systemic inflammation tested via blood biomarkers

  Baseline

• Systemic inflammation tested via blood biomarkers

  5 weeks after baseline

• Systemic inflammation tested via biomarkers

  10 weeks after baseline

• Systemic inflammation tested via blood biomarkers

  15 weeks after baseline

• Autonomic nervous system measured through non-invasive ECG

  Baseline

Other Outcomes (32)

• Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol

  Baseline

• Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol

  5 weeks after baseline

• Peak VO2 (oxygen consumption) measured via modified Balke treadmill protocol

  10 weeks after baseline

Study Arms (2)

Aerobic Exercise Training

EXPERIMENTAL

Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.

Other: Aerobic Exercise Training

Attention Control

ACTIVE COMPARATOR

The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.

Other: Attention Control

Interventions

Aerobic Exercise Training OTHER

Each session will last 20 to 60 minutes depending on the stage of progression (shorter duration in the first few weeks). Sessions will occur on nonconsecutive days of the week. Moderate-intensity, continuous aerobic exercise will be used to target large muscle groups (e.g., legs) with the principal goal of increasing cardiorespiratory fitness. Exercise intensity will be gradually increased. To mitigate stagnation and support continued improvement of cardiorespiratory fitness, high-intensity interval exercise will be added in later weeks of the intervention.

Aerobic Exercise Training

Attention Control OTHER

The flexibility/toning control condition will be delivered using the same frequency as the aerobic condition (i.e., 3 times per week) and use light resistance bands of least difficulty. The flexibility/toning sessions will last about 40 minutes, be led by trained exercise specialists. Flexibility/toning activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, and ankle/foot. The progression of activities over the 10-week period will involve performing additional exercises and sets along with using progressively thicker elastic resistance bands (i.e., Thera-bands) that provide minimal resistance.

Attention Control

Eligibility Criteria

• Age: 18 Years - 74 Years
• Gender Eligibility Details: self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-001, United States

Location

Related Publications (1)

• Little 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Fatigue; Inflammation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Laura Q Rogers, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to participant study group allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 3, 2019
• First Posted: September 13, 2019
• Study Start: January 17, 2020
• Primary Completion: September 5, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: To be determined
• Access Criteria: To be determined

Locations

US (1)