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Study of Aerobic Training for People Receiving Treatment for Breast Cancer

NCT05716893 · Memorial Sloan Kettering Cancer Center
In plain English

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Official title
Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Treatment for Primary Breast Cancer
About this study
In this study, investigators will compare standard Aerobic Training/AT with adaptive Aerobic Training/AT. Standard AT will be a fixed (unchanging) amount of walking each week, while adaptive AT will adjust the level of exercise depending on participants' response to the exercise. Investigators will see how both study approaches (standard AT and adaptive AT) affect participants' CRF.
Eligibility criteria
Inclusion Criteria: * Aged ≥18 years * Female * Diagnosed with primary breast cancer as defined by one of the following: * Histological confirmation * As per standard of care imaging * Scheduled to receive neoadjuvant/adjuvant systemic and/or locoregional therapy * Performing ≤90 minutes of moderate- and/or strenuous-intensity exercise per week, as evaluated by self-report * Willingness to comply with all study-related procedures * Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria: 1. Achieving a plateau in oxygen consumption, concurrent with an increase in power output; 2. A respiratory exchange ratio ≥ 1.10; 3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]); 4. Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. Exclusion Criteria: * Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes * Receiving treatment for any other diagnosis of invasive cancer * Distant metastatic malignancy of any kind * Mental impairment leading to inability to cooperate * Any of the following contraindications to cardiopulmonary exercise testing: i. Acute myocardial infarction within 3-5 days of any planned study procedures; ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Respiratory failure; xv. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) xvi. Room air desaturation at rest ≤ 85% * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Study design
Enrollment target: 140 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-01-30
Estimated completion: 2028-01-30
Last updated: 2026-08-27
Interventions
Behavioral: Adaptive Aerobic Training/AT DosingBehavioral: Standard (fixed) Aerobic Training/AT dosing
Primary outcomes
  • Cardiorespiratory fitness (CRF) response rate (32 weeks from baseline)
Sponsor
Memorial Sloan Kettering Cancer Center · other
Contacts & investigators
ContactJessica Scott, PhD · contact · scottj1@mskcc.org · 646-888-8093
ContactAnthony Yu, MD · contact · yua3@mskcc.org · 212-639-5154
InvestigatorJessica Scott, PhD · principal_investigator, Memorial Sloan Kettering Cancer Center
All locations (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited protocol activities)Recruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Recruiting
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)Recruiting
Rockville Centre, New York, United States