Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294-001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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

Ages Eligible for Study

18 Years to 74 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Laura Q Rogers, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2025-08-31