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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Aerobic Training/AT Dosing | Experimental | Participants with newly diagnosed primary breast cancer initiating chemotherapy. |
|
| Standard (fixed) Aerobic Training/AT dosing | Active Comparator | Participants with newly diagnosed primary breast cancer initiating chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Aerobic Training/AT Dosing | Behavioral | o In Phase A (~32 weeks), AT will consist of supervised walking delivered up to 7 days per week using an adaptive dosing schedule that starts at 90 min/wk and is escalated 30 min/wk every 2 weeks to a maximal dose of 300 mins/wk. In Phase B (~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF Δ>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness (CRF) response rate | The primary endpoint will be CRF response rate as assessed by the proportion of patients with a peak oxygen consumption (VO2peak; ml O2 .kg-1.min-1 ) change from baseline (T0) to T2 (~32 weeks) of ≥3.50 ml O2 .kg-1.min-1 . A CRF change ≥3.50 ml O2 .kg-1.min-1 will be considered a response; a change <3.50 ml O2 .kg-1.min-1 will be considered a non-response. | 32 weeks from baseline |
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Inclusion Criteria:
Aged ≥18 years
Female
Diagnosed with primary breast cancer as defined by one of the following:
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:
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](streamdown:incomplete-link)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Scott, PhD | Contact | 646-888-8093 | scottj1@mskcc.org | |
| Anthony Yu, MD | Contact | 212-639-5154 | yua3@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Scott, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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|
| Standard (fixed) Aerobic Training/AT dosing | Behavioral | In Phase A (~32 weeks), AT will consist of supervised walking delivered up to 7 days per week to achieve a cumulative total duration of: 90 min/wk (standard fixed dosing). In Phase B (~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF Δ>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx. |
|
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Limited protocol activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (Limited protocol activities) | Recruiting | Rockville Centre | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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