Breast Cancer
Conditions
Keywords
Breast Cancer, Exercise, Chemotherapy, 15-178
Brief summary
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.
Interventions
BEHAVIORALAerobic Training
BEHAVIORALEducational Information
Subjects will be given material regarding cancer and it's impact.
BEHAVIORALSupervised Home Based Training
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 21-80 years * Female * MSK histologically confirmed early-stage operable breast cancer * Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting * ECOG status of 0 or 1 * Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week * 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 complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator. * Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria: * Achieving a plateau in oxygen consumption, concurrent with an increase in power output; * A respiratory exchange ratio ≥ 1.10; * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]); * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. * Willingness to be randomized to one of the study arms
Exclusion criteria
* 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 metastatic disease * Any of the following contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction within 3-5 days of any planned study procedures) * Unstable angina * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Symptomatic severe aortic stenosis * Uncontrolled heart failure * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; * Thrombosis of lower extremities * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Respiratory failure * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) or * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VO2 peak (functional capacity) | during chemotherapy 3-6 months depending on treatment recommendations | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life measured by questionnaire during and after Chemotherapy | at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing | Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy. |
| Sleeping patterns as measured by questionnaire during and after Chemotherapy | at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing | Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy. |
| Depression scale during and after Chemotherapy | at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing | Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy. |
| Physical activity recall during and after Chemotherapy | at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing | Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy. |
| Skeletal Muscle Function | at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing | To examine the physiological mediators of the exercise training - exercise capacity relationship (e.g., skeletal muscle function as assessed by a muscle biopsy)performed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Scott, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed