High-Intensity Interval Training for Stage I-III Breast Cancer Patients

Stopped early · Not applicable

Conditions studied: Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

In brief

This randomized pilot clinical trial studies the feasibility of high-intensity interval training in improving cardiovascular fitness in patients with stage I-III breast cancer undergoing chemotherapy with trastuzumab. Trastuzumab helps patients live longer, but may cause side effects to the heart. Aerobic exercise may help the heart function better, which may help protect it against side effects from trastuzumab. Exercise may also help reduce fatigue and prevent cancer from coming back. High-intensity interval training involves short bursts of higher intensity efforts with longer periods of recovery. This may also allow patients who cannot exercise for a long period of time to still be physically active. This trial studies whether patients can tolerate high-intensity interval training, and how well it works in improving fitness in patients with breast cancer receiving trastuzumab.

Key facts

Study ID

NCT02454777

Run by

University of Southern California

People needed

31

Starts

2015-09-29

Expected to finish

2019-07-15

Last updated by the study team

2021-04-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• English or Spanish speaking
• Diagnosed with early stage (I-III) breast cancer, without evidence of metastatic disease
• Planned (neo)adjuvant therapy with trastuzumab (Herceptin) and/or anthracycline-based chemotherapy
• Not currently pregnant or planning to become pregnant throughout the duration of cancer treatment
• Physician (oncologist) clearance to participate in exercise at moderate to high intensity
• Have read and signed study informed consent document (ICF)
• EXERCISE INCLUSION CRITERIA:
• Normal body temperature (=< 100 degrees F)
• Resting blood pressure and/or heart rate within normal limits
• Participants have not received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session

You may not qualify if…

• Advanced stage (stage IV) or metastatic breast cancer diagnosis (screening for metastases with scans only needed if there is clinical suspicion for metastases)
• Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
• Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc.)
• Moderate to highly active level of physical activity (e.g. currently participating in >= 60 minutes of moderate aerobic activity weekly)
• Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
• EXERCISE EXCLUSION CRITERIA:
• Presence of fever (>= 100 degrees F)
• Resting blood pressure and/or heart rate outside normal limits
• Participants have received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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