Recruiting

Exercise

Sponsor:

University of Florida

Code:

NCT05684367

Conditions

Fatigue

Breast Cancer

Cancer, Therapy-Related

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Center-Based Walking Exercise

Home-Based Walking Exercise

Study Details

Brief summary:

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.

Conditions

Fatigue

Breast Cancer

Cancer, Therapy-Related

Study ID

NCT05684367

Start date

Nov 29, 2023

Status verified date

Feb, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Center-Based Walking Exercise

Subjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study.

experimental: Home-Based Walking Exercise

Subjects will be randomly assigned to walk for exercise in their community five days/week.

Interventions

Center-Based Walking Exercise

Each exercise session will begin with a short warm-up followed by 30 min of walking. Participants will initially be instructed to walk at a moderate intensity, equivalent to a 5-6 on Borg category-ratio (CR) scale. Participants will be encouraged to, if possible, incorporate brief periods of vigorous walking (7-8 on CR10 scale) with a goal of achieving at least 10 min of vigorous walking per session.

Home-Based Walking Exercise

Participants will be asked to walk for exercise in their community five days/week. Participants will be instructed to begin with 10-15 minutes of walking exercise/session in the first month of the intervention and to increase exercise duration by five minutes/session each week, facilitating reasonable but steady progress toward the goal of 30 minutes per session.

Primary outcome measure

  • Self-Reported Fatigue [ Time Frame: Baseline up to Week 8 ]

Central Contacts and Locations

Locations

Institute on Aging; University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Stephen D Anton, PhD

352-273-7514santon@ufl.edu

Principal Investigator:

Stephen D Anton, PhD

More Information

Sponsor

University of Florida

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-02-05.