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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes.
The researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.
Prior to the initiation of every supervised aerobic training session, patient resting vital signs will be assessed to ensure the patient can safely proceed with the session. Vital signs, including resting heart rate and blood pressure, will be collected and monitored per ExOnc program guidelines. In addition, the planned session will not be initiated if the ExOnc staff member observes any concerns that may compromise participant safety and/or the integrity of the planned session. Vital sign monitoring guidelines for unsupervised sessions, prescribed at lower intensities, will be advised by the exercise physiologist at the time the session plan is provided to the patient. Patients will be instructed to not begin an unsupervised session if their resting heart rate or blood pressure is outside the recommended guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (A) breast cancer after completion of chemo | Experimental | 300 min/wk for 16 weeks, followed by 16 weeks of usual care. |
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| (B) breast cancer after completion of chemo | Experimental | 150 min/wk for 32 weeks. |
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| (C) breast cancer after completion of chemo | Experimental | 300 min/wk for 32 weeks. |
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| (D) breast cancer after completion of chemo | Active Comparator | 150 min/wk for 16 weeks, followed by 16 weeks of usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Training | Other | 300 min/wk for 16 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate | A CRF change ≥1.32 ml O2.kg-1.min-1 will be considered a response; a change <1.32 ml O2.kg-1.min-1 will be considered a non-response. | 32 weeks |
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Inclusion Criteria:
Aged 21-80 years
Female
Surgically resected early stage (I-III) primary breast cancer
Post-menopausal, defined as one of the following:
An interval of at least one year, but no more than five years, following the full completion of definitive therapy for malignant disease. Definitive therapy is defined as:
Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min)].
Note: Normative values are available up to 80 years of age)
Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria:
Willingness to comply with all study-related procedures.
Exclusion Criteria:
Any of the following absolute contraindications to cardiopulmonary exercise testing:
Presence of any other concurrent, actively treated malignancy
History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
Presence of distant metastatic disease (i.e., stage IV)
Room air desaturation at rest ≤ 85%
Mental impairment leading to inability to cooperate.
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial.](streamdown:incomplete-link)
Post-Menopausal Women After Treatment for Early Stage Breast Cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Scott, PhD | Contact | 646-888-8103 | scottj1@mskcc.org | |
| Lee Jones, PhD | Contact | 646-888-8103 |
| Name | Affiliation | Role |
|---|---|---|
| Jessica Scott, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only) | Recruiting | Hartford | Connecticut | 06102 | 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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This is a single-center randomized controlled trial (RCT) study designed to evaluate the cardiorespiratory fitness (CRF) response rate to different aerobic therapy (AT) doses in patients with post-treatment primary breast cancer.
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| Aerobic Training |
| Other |
150 min/wk for 32 weeks |
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| Aerobic Training | Other | 300 min/wk for 32 weeks |
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| Aerobic Training | Other | 150 min/wk for 16 weeks |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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