RECRUITING

Exercise to ReGain Stamina and Energy (The EXERGISE Study)

Conditions

Fatigue Breast Cancer Cancer, Therapy-Related

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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

About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. The purpose of this study is to test types of walking exercise interventions and their ability to reduce fatigue in older breast cancer survivors.

Official Title

Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors

Quick Facts

Study Start:2023-11-29

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05684367

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:60 Years to 105 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Consent to participate in the study * Age ≥ 60 years old * Had stage I-III invasive breast cancer * The cancer is diagnosed in 2021 or 2022 * Completed adjuvant therapy for at least 3 months but no more than 1 year * Willingness to participate in all study procedures * Had at least moderate-level fatigue (defined as raw score ≥ 8 on the PROMIS Measure)	* Failure to provide informed consent * Current involvement in rehabilitation program * Absolute contraindications to exercise training * Significant cognitive impairment * Progressive, degenerative neurologic disease * Hip fracture, hip or knee replacement, or spinal surgery within past 4 months * Other significant comorbidities that may impair ability to participate in the exercise intervention * Pregnant * Regular consumption of nicotinamide riboside supplement * Simultaneous participation in other interventional studies * Had no or very mild fatigue (defined as raw score ≤7 in PROMIS) * Diagnosis of any of the following medical conditions in past three years (coronary heart disease, angina, heart attack, heart failure, stroke, high blood pressure, chronic obstructive pulmonary disease, chronic bronchitis, arthritis, diabetes mellitus, and chronic kidney disease), as measured by Behavioral Risk Factor Surveillance System * Receipt of any oral or intravenous antibiotic 4 weeks prior to screening * Receipt of any probiotics within 4 weeks of screening * History of active treatment for HIV, hepatitis B, or hepatitis C infection * Positive stool cultures for enteric pathogens, including Clostridium difficile * Excessive alcohol use (i.e., \> 14 drinks/week) or alcohol abuse (i.e., \> 5 drinks/day for males or \> 4 drinks/day for females) * Other substance abuse within the past 3 years * Smoking history in past 3 years

Inclusion Criteria

Exclusion Criteria

* Consent to participate in the study
* Age ≥ 60 years old
* Had stage I-III invasive breast cancer
* The cancer is diagnosed in 2021 or 2022
* Completed adjuvant therapy for at least 3 months but no more than 1 year
* Willingness to participate in all study procedures
* Had at least moderate-level fatigue (defined as raw score ≥ 8 on the PROMIS Measure)

* Failure to provide informed consent
* Current involvement in rehabilitation program
* Absolute contraindications to exercise training
* Significant cognitive impairment
* Progressive, degenerative neurologic disease
* Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
* Other significant comorbidities that may impair ability to participate in the exercise intervention
* Pregnant
* Regular consumption of nicotinamide riboside supplement
* Simultaneous participation in other interventional studies
* Had no or very mild fatigue (defined as raw score ≤7 in PROMIS)
* Diagnosis of any of the following medical conditions in past three years (coronary heart disease, angina, heart attack, heart failure, stroke, high blood pressure, chronic obstructive pulmonary disease, chronic bronchitis, arthritis, diabetes mellitus, and chronic kidney disease), as measured by Behavioral Risk Factor Surveillance System
* Receipt of any oral or intravenous antibiotic 4 weeks prior to screening
* Receipt of any probiotics within 4 weeks of screening
* History of active treatment for HIV, hepatitis B, or hepatitis C infection
* Positive stool cultures for enteric pathogens, including Clostridium difficile
* Excessive alcohol use (i.e., \> 14 drinks/week) or alcohol abuse (i.e., \> 5 drinks/day for males or \> 4 drinks/day for females)
* Other substance abuse within the past 3 years
* Smoking history in past 3 years

Contacts and Locations

Principal Investigator

Stephen Anton

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

Institute on Aging; University of Florida

Gainesville, Florida, 32611

United States

Collaborators and Investigators

Sponsor: University of Florida

Stephen Anton, PRINCIPAL_INVESTIGATOR, University of Florida

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 Date2023-11-29

Study Completion Date2025-08

Study Record Updates

Study Start Date2023-11-29

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Fatigue
Breast Cancer
Cancer, Therapy-Related