Clinical trial NCT05684367: Exercise to ReGain Stamina and Energy (The EXERGISE Study)
Official title: Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fatigue
Breast Cancer
Cancer, Therapy-Related
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Women with breast cancer often experience severe fatigue (asthenia) after cancer therapy, seen in approximately 40% of breast cancer survivors. Because older age is a risk factor for fatigue, older breast cancer survivors are at an increased risk versus those in younger age groups. Prior evidence suggests that aerobic exercise reduces inflammation and bioenergenesis disturbance, which are key factors that drive the pathogenesis of fatigue. Although interventional studies suggest that aerobic exercise can improve fatigue in younger breast cancer survivors, anti-fatigue effects of aerobic exercise tended to decrease with increasing age. The investigators postulate that novel interventions combined with aerobic exercise can enhance its effectiveness and alleviate severe fatigue further in older breast cancer survivors.

In this pilot randomized clinical trial, the investigators will enroll 24 female cancer survivors aged ≥ 60 years who were diagnosed with invasive breast cancer but have completed adjuvant therapy for at least 3 months but no more than 1 year. Participants will be randomly assigned to either a center-based walking exercise intervention or a home-based walking exercise intervention for an 8 week period. By completing this pilot study, the investigators will be able to collect preliminary data; refine the recruitment, measurement, randomization, and retention strategy; and adjust the statistical strategy and timeline for the potential full-scale randomized clinical trial.

Eligibility criteria: 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

Primary outcomes:
measure: Self-Reported Fatigue
timeFrame: Baseline up to Week 8
Secondary outcomes:
measure: Mental Distress (Depression and Anxiety)
timeFrame: Baseline up to Week 8
measure: Self-Reported Pain
timeFrame: Baseline up to Week 8
measure: Self-Reported Sleep Disturbance
timeFrame: Baseline up to Week 8
measure: Gait Speed
timeFrame: Baseline up to Week 8
measure: Physical Function
timeFrame: Baseline up to Week 8
measure: Treatment-Induced Peripheral Neuropathy (TIPN)
timeFrame: Baseline up to Week 8
measure: Habitual Physical Activity
timeFrame: Baseline up to Week 8
measure: Functional Assessment of Cancer Therapy - Breast (FACT-B)
timeFrame: Baseline up to Week 8
measure: Perceived Stress
timeFrame: Baseline up to Week 8
measure: Dispositional Gratitude
timeFrame: Baseline up to Week 8
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Institute on Aging; University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Stephen Anton
role: PRINCIPAL_INVESTIGATOR
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