Exercise Intervention After Cancer Treatment for Improving Health in Stage II-III Breast Cancer Survivors

PRIMARY OBJECTIVES:

I. Estimate the adherence rate of the experimental exercise program, and deem as feasible if
at least 80% of participants complete 80% or more of a 12-week, 180 minute aerobic+resistance
training program that combines structured, individualized onsite exercise at the Fred Hutch
Prevention Center with at-home exercise.

II. Identify up to 5 circulating micro ribonucleic acid (c-miRNA) biomarkers that show the
largest differential change from baseline when comparing levels in the exercise program to
those in the Fitbit-activity control condition.

SECONDARY OBJECTIVES:

I. Explore associations between changes in miRNAs and serum biomarkers (IL-6, lipids,
adiponectin and leptin, C-reactive protein [CRP]) and physiological outcomes (resting heart
rate, blood pressure, 1 repetition max, 6 minute walk, timed up and go test) of the exercise
program.

II. Explore changes in the patient-reported outcomes (PRO) in response to the exercise
intervention relative to the control group, and finalize measures to use in the design of the
phase III clinical trial based on descriptive changes from baseline to follow-ups in the
intervention versus (vs.) control groups.

OUTLINE: Participants are randomized into 1 of 2 arms.

ARM 0: Participants wear Fitbit and receive written information on healthy exercise and diet
recommendations.

ARM 1: Participants complete exercise program including aerobic and resistance exercises over
60 minutes 3 times per week for 12 weeks. Exercise is supervised all 3 times during weeks
1-2. During weeks 3-12, exercise is supervised 2 times a week, with home-based coaching for
an additional 60 minutes a week.

Inclusion Criteria:

- Single malignancy with diagnosis of breast cancer diagnosis of stage II-III, estrogen
and progesterone positive, HER-2neu negative, and on stable dose of aromatase
inhibitor (AI) for past 3 months, with AI expected to be stable for the study duration

- No evidence of disease

- 1-5 years post active treatment for malignancy

- Body mass index 19 to 35

- Sedentary (< 100 minutes of moderate intensity exercise per week)

- English adequate to complete assessments and follow exercise instructions

- Able to independently use transportation to attend 2-day a week onsite exercise
training

- Access to a computer or smartphone

Exclusion Criteria:

- Current tobacco use or electronic cigarette smoker

- Pregnant

- Diabetes requiring insulin injection

- Lymphedema that restricts range of motion or with worsening symptoms in the past
month, or without compression garment

- Weight change of more than 10 pounds in previous 3 months will exclude from study
participation at baseline

- Medical or other issue impacting exercise ability or safety, or ability to comply with
study procedures (e.g. significant vision or cognitive impairment, major illness, in
hospital or other institution), and specifically:

- Have been hospitalized within 3 months prior to screening for major
atherosclerotic events (e.g. myocardial infarction, target-vessel
revascularization, coronary bypass surgery, stroke or blood clot) or other major
medical condition (as determined by an investigator) that may put the subject at
risk because of his/her participation in the study;

- Have an implanted cardiac pacemaker or other implanted cardiac device;

- Have chronic, uncontrolled hypertension as judged by the investigator;

- Have a creatinine clearance < 45 mL/min as calculated by the Cockcroft-Gault
equation;

- Subject's hand or legs have mobility impairment from fractures, arthritis,
surgery, muscle disease or other injury that may interfere with any study
procedure or ability to exercise