ACTIVE_NOT_RECRUITING

Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

Conditions

Breast Cancer Gut Microbiome Exercise Fatigue psychosocial outcomes inflammation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-01-17

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04088708

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.

Ages Eligible for Study:18 Years to 74 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Laura Q Rogers, MD, MPH

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-001

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-17

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2020-01-17

Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

breast cancer
fatigue
exercise
psychosocial outcomes
inflammation
gut microbiome

Additional Relevant MeSH Terms

Breast Cancer
Gut Microbiome
Exercise
Fatigue