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

PRIMARY OBJECTIVES:

I. To assess the feasibility (completion of > 80% exercise sessions) of utilizing
high-intensity interval training (HIT).

II. To determine the effects of HIT on aerobic exercise adaptation when compared to delayed
group.

III. To examine the effects of HIT on left ventricular function when compared to delayed
group.

IV. To determine the effects of HIT on endothelial function, arterial stiffness, and vascular
atherosclerosis when compared to delayed group.

OUTLINE: Participants are randomized to 1 of 2 groups.

ARM I: HIT (High-intensity Interval Training) group - Participants undergo HIT over 30
minutes, thrice weekly for 8 weeks.

ARM II: DEL (Delayed/usual care) group - Participants maintain their current sedentary
activity level (< 60 minutes of total exercise per week) for 8 weeks. Participants document
their weekly activity in an exercise log. Following completion of all study visits,
participants are given the option to complete the HIT exercise program as in Arm I.

After completion of study, patients are followed up at weeks 9 and 17.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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