Memorial Sloan Kettering Cancer Center
New York, 10065, United States
NCT Number: NCT01943695
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.
This study is active but is not currently recruiting participants.
Notify Me21 year–80 year
Female
Interventional
Not applicable
New York, 10065, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a. Women < 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy.
Exclusion criteria
Other names: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Memorial Sloan Kettering Cancer Center
Other
Optimal Timing Trial: Randomized Trial of Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04589468
Behavior, Breast Cancer
Duarte, California, United States
View Trial DetailsNCT05931874
Behavior, Breast Cancer
Chicago, Illinois, United States
View Trial DetailsNCT01504789
Behavior, Breast Cancer
Houston, Texas, United States
View Trial DetailsNCT01621659
Behavior, Breast Cancer
Edmonton, Alberta, Canada
View Trial Details