Study of Aerobic Training for People Receiving Treatment for Breast Cancer
Recruiting
Phase 2Interventional Study
Breast CancerBreast Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
140 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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 mo…
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
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