Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for women aged 21-80 with early-stage operable breast cancer scheduled for chemotherapy, not doing more than 150 minutes of moderate to strenuous exercise weekly. They must pass a baseline exercise test without high-risk heart issues and can't be pregnant or planning pregnancy during the study. Those with other active cancers, metastatic disease, certain heart/lung conditions, mental impairments, or treated malignancies within 3 years (except skin cancer) are excluded.Inclusion Criteria
You don't exercise for at least 150 minutes per week at a moderate or vigorous level.
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
I am fully active or can carry out light work.
+7 more
Exclusion Criteria
You have a health problem that can affect your ability to exercise or could get worse with exercise.
Your oxygen levels drop to 85% or lower when you are resting without extra oxygen.
You have a mental condition that makes it hard for you to work together with the study team.
+5 more
Participant Groups
The study examines the impact of supervised aerobic exercise training on women undergoing chemotherapy for early-stage breast cancer. Participants will either perform exercises during or after their chemo treatment and report back to staff about their sessions.
4Treatment groups
Experimental Treatment
Group I: General Physical Activity GroupExperimental Treatment2 Interventions
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.
Group II: Continuous Aerobic TrainingExperimental Treatment1 Intervention
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.
Group III: Aerobic Training During ChemotherapyExperimental Treatment1 Intervention
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.
Group IV: Aerobic Training After ChemotherapyExperimental Treatment1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Cancer CenterNew York, NY
Loading ...
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor