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Study of Aerobic Training for People Receiving Treatment for Breast Cancer

RecruitingPhase 2

Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Treatment for Primary Breast Cancer

Who can join

Ages 18 and older · Women

Full 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

About the 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.

What is being tested

Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 140 · Started: Jan 30, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05716893

Locations in the U.S.

New JerseyMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
Memorial Sloan Kettering Bergen (Limited protocol activities), Montvale
New YorkMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York
Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.