Walking exercise to reduce fatigue in older breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical trial aims to evaluate the effectiveness of two types of walking exercise interventions—center-based and home-based—on reducing fatigue in older women who have survived invasive breast cancer. The study will enroll 24 female participants aged 60 and older who have completed their cancer treatment within the last year and are experiencing moderate to severe fatigue. Participants will be randomly assigned to one of the two exercise groups for an 8-week period, allowing researchers to gather preliminary data and refine methodologies for a potential larger study. The focus is on understanding how aerobic exercise can alleviate fatigue, particularly in older survivors who may not respond as well to traditional interventions.

Why it matters

Who can join: the full rules

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

Where it's running

• Institute on Aging; University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Stephen Anton — University of Florida

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.