Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer

Cancer related fatigue (CRF) is a common and debilitating side effect of radiotherapy in
breast cancer patients. Physical activity interventions can attenuate CRF. The proposed study
is a randomized, controlled trial (RCT) of exercise of structured moderate-intensity exercise
intervention, delivered concurrently with radiotherapy, to reduce CRF and improve
health-related quality of life among breast cancer patients. Eighty women with breast cancer
scheduled to receive radiation therapy at Hackensack University Medical Center (HUMC) will be
randomized to one of the two trial arms:1) a facility-based aerobic exercise utilizing a
portable stationary pedal exerciser; or 2) a control group. Intervention arm participants
will exercise at the hospital either before or after their radiation treatment. Assessments
will be conducted at baseline, 4 weeks into radiation course, and at 4-week follow-up visit.
The outcome variables are CRF, biomarkers of inflammation, and health-related quality of life
(QOL). The study will provide preliminary evidence on whether a short-term moderate-intensity
exercise intervention might be effective in reducing CRF in women undergoing radiotherapy for
breast cancer, and whether this effect is mediated by inflammation.

Inclusion Criteria:

1. women between the ages of 18 and 75 years

2. histologically confirmed non-metastatic carcinoma of the breast (in situ disease or
invasive)

3. radiation therapy naïve

4. sedentary activity level at baseline, as defined by less than 60 minutes per week of
modest physical activity based on 7-day physical activity recall questionnaire

5. ambulatory

6. negative serum pregnancy test and not planning to become pregnant in the next three
months

7. able to provide meaningful consent.

8. Patients must have been deemed by their medical oncologist or internist that they "may
participate in [this] exercise trial." Prior to randomization, participants are
required to complete a Physical Activity Readiness Questionnaire (PAR-Q) that includes
questions regarding physical and medical conditions that would preclude safe
participation in an exercise program.

Exclusion Criteria:

1. younger than 18 or older than 75 years

2. no histological confirmation of breast cancer

3. prior breast, chest, or pelvic radiotherapy

4. concurrent chemotherapy

5. distant metastases

6. physical limitations that contraindicate participation in low to moderate intensity
exercise

7. positive pregnancy test

8. currently engaged in moderate to vigorous physical activity

9. psychiatric disorder which would render the participant unable to provide informed
consent.