Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

NCT ID: NCT04088708

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-17
• Study Completion Date: 2026-08-31

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.

Conditions

Breast Cancer; Gut Microbiome; Exercise; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Aerobic Exercise Training

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

Group Type: EXPERIMENTAL

Aerobic Exercise Training

Intervention Type: 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.

Attention Control

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

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: 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.

Interventions

Aerobic Exercise Training

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.

Intervention Type: OTHER

Attention Control

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Laura Q. Rogers, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Q Rogers, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38702085 (View on PubMed)

Other Identifiers

R01CA235598

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-30000320

Identifier Type: -

Identifier Source: org_study_id