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ACTIVE NOT RECRUITING

NCT04088708

Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Official title: Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)

Key Details

Gender

FEMALE

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2020-01-17

Completion Date

2026-08-31

Last Updated

2025-09-16

Healthy Volunteers

Conditions

Breast Cancer Gut Microbiome Exercise Fatigue

Interventions

OTHER

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.

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.

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States