An interventional study of Aerobic Training and Educational Information in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 1 site in United States. Open to female participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Supportive care
The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer.
The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 144 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
a. Women \< 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy.
Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:
Exclusion Criteria:
The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training an intensity of at 55% to 100% of the individually determined exercise capacity VO2peak), concurrent with chemotherapy. VO2peak will be determined by the CPET performed at baseline. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Behavioral: Aerobic Training
The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training at an intensity 55% to 100% of the individually determined exercise capacity (VO2peak), after the completion of chemotherapy. VO2peak will be determined by the CPET performed at midpoint, or pre-surgery for neoadjuvant patients. For patients receiving adjuvant therapy, (except those who have additional surgery after chemotherapy), the aerobic training intervention must begin within 2 weeks of the patient's midpoint CPET. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, the aerobic training intervention will begin within approximately 6 weeks of surgery, per the discretion of the treating physician. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Behavioral: Aerobic Training
The ultimate goal is for participants to complete 3 exercise sessions week of non-linear aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), during and after chemotherapy. For patients receiving adjuvant therapy (except those who have additional surgery after chemotherapy), VO2peak will be determined by the CPETs performed at baseline and midpoint. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, VO2peak will be determined by the CPETs or at baseline, pre- surgery, and post-surgery. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Behavioral: Aerobic Training
Patients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, consultation with a staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of their normal daily activity. Patients can be provided with a fitness tracker (e.g. FitBit) to evaluate exercise duration and intensity. Patients may also be provided with an exercise log to record type, duration, and average heart rate during sessions. The exercise log is provided as a guidance tool and may be, although is not required to be, returned to study staff. Staff exercise physiologists will contact patients to check progress, and answer questions.
Behavioral: Educational Information · Behavioral: Supervised Home Based Training
Also known as: exercise, breast cancer, therapy.
Subjects will be given material regarding cancer and it's impact.
Patients that elect supervised home based training platform or plan to complete unsupervised training sessions will receive a study kit which includes a heart rate monitor, blood pressure cuff, treadmill and tablet to complete aerobic training requirements. The study kit will be given to the patient upon completion of their baseline testing. The treadmill will be shipped to the patient's home and coordinated by the Ex Onc group. The treadmills are MSK owned equipment that will be deployed to the patient's homes via the vendor TechnoGym. A member of Ex Onc will provide an orientation session for the patient to set up all study kit items. If there is a delay in the patient receiving the treadmill , or any other unforeseen circumstance, patients may be assigned a temporary unsupervised training program until the treadmill is delivered.
Change in VO2 peak (functional capacity)
To determine the optimal timing of aerobic activity, relative to an attention-control group, on exercise capacity in a breast cancer setting. This will be evaluated using an electronic motorized treadmill test with 12-lead ECG monitoring (Mac® 5000, GE Healthcare) performed by certified exercise physiologists.
Time frame: during chemotherapy 3-6 months depending on treatment recommendations
Quality of Life measured by questionnaire during and after Chemotherapy
Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.
Time frame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
Sleeping patterns as measured by questionnaire during and after Chemotherapy
Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.
Time frame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
Depression scale during and after Chemotherapy
Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.
Time frame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
Physical activity recall during and after Chemotherapy
Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.
Time frame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
Skeletal Muscle Function
To examine the physiological mediators of the exercise training - exercise capacity relationship (e.g., skeletal muscle function as assessed by a muscle biopsy)performed.
Time frame: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center