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

Overview

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.

Interventions

• Behavioral 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.
• Behavioral 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 measures

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

Secondary outcome measures (10)

• Mental Distress (Depression and Anxiety) [Time frame: Baseline up to Week 8]
• Self-Reported Pain [Time frame: Baseline up to Week 8]
• Self-Reported Sleep Disturbance [Time frame: Baseline up to Week 8]
• Gait Speed [Time frame: Baseline up to Week 8]
• Physical Function [Time frame: Baseline up to Week 8]
• Treatment-Induced Peripheral Neuropathy (TIPN) [Time frame: Baseline up to Week 8]
• Habitual Physical Activity [Time frame: Baseline up to Week 8]
• Functional Assessment of Cancer Therapy - Breast (FACT-B) [Time frame: Baseline up to Week 8]
• Perceived Stress [Time frame: Baseline up to Week 8]
• Dispositional Gratitude [Time frame: Baseline up to Week 8]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Institute on Aging; University of Florida — Gainesville

Publications

• Martin CB, Herrick KA, Sarafrazi N, Ogden CL. Attempts to Lose Weight Among Adults in the United States, 2013-2016. NCHS Data Brief. 2018 Jul;(313):1-8. PMID 30044214
• Demb J, Abraham L, Miglioretti DL, Sprague BL, O'Meara ES, Advani S, Henderson LM, Onega T, Buist DSM, Schousboe JT, Walter LC, Kerlikowske K, Braithwaite D; Breast Cancer Surveillance Consortium. Screening Mammography Outcomes: Risk of Breast Cancer and Mortality by Comorbidity Score and Age. J Natl Cancer Inst. 2020 Jun 1;112(6):599-606. doi: 10.1093/jnci/djz172. PMID 31593591
• Hamer J, McDonald R, Zhang L, Verma S, Leahey A, Ecclestone C, Bedard G, Pulenzas N, Bhatia A, Chow R, DeAngelis C, Ellis J, Rakovitch E, Lee J, Chow E. Quality of life (QOL) and symptom burden (SB) in patients with breast cancer. Support Care Cancer. 2017 Feb;25(2):409-419. doi: 10.1007/s00520-016-3417-6. Epub 2016 Sep 30. PMID 27696078
• Phillips RO. A review of definitions of fatigue - And a step towards a whole definition. Transport Res F-Traf. 2015;29:48-56.
• Campos MPO, Hassan BJ, Riechelmann R, Del Giglio A. Cancer-related fatigue: a practical review. Ann Oncol. 2011 Jun;22(6):1273-1279. doi: 10.1093/annonc/mdq458. Epub 2011 Feb 16. PMID 21325448
• Fu OS, Crew KD, Jacobson JS, Greenlee H, Yu G, Campbell J, Ortiz Y, Hershman DL. Ethnicity and persistent symptom burden in breast cancer survivors. J Cancer Surviv. 2009 Dec;3(4):241-50. doi: 10.1007/s11764-009-0100-7. Epub 2009 Oct 27. PMID 19859813
• Abrahams HJG, Gielissen MFM, Schmits IC, Verhagen CAHHVM, Rovers MM, Knoop H. Risk factors, prevalence, and course of severe fatigue after breast cancer treatment: a meta-analysis involving 12 327 breast cancer survivors. Ann Oncol. 2016 Jun;27(6):965-974. doi: 10.1093/annonc/mdw099. Epub 2016 Mar 2. PMID 26940687
• Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life. J Clin Oncol. 2000 Feb;18(4):743-53. doi: 10.1200/JCO.2000.18.4.743. PMID 10673515

Identifiers

NCT: NCT05684367 · IRB202202679 · OCR42286 · IRB202102537

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗