Exercise Program During Chemotherapy in Metastatic Colorectal Cancer

PRIMARY OBJECTIVES:

I. To determine whether a 6-week indoor or outdoor aerobic exercise program is feasible in
patients with metastatic colorectal cancer (mCRC) undergoing chemotherapy and to explore
patient's preferences for indoor versus (vs.) outdoor exercise.

II. To determine the effects of a 6-week indoor or outdoor aerobic exercise program on
cancer-related fatigue and quality of life (QOL) in patients with mCRC.

SECONDARY OBJECTIVES:

I. To determine the effects of a 6-week indoor or outdoor aerobic exercise program on body
composition (lean body mass, fat mass, body fat percentage [%]) and biomarkers of systemic
inflammation (interleukin-6 [IL-6], tumor necrosis factor alpha [TNF-a], C-reactive protein
[CRP]) in patients with mCRC.

TERTIARY OBJECTIVES:

I. To determine the effects of a 6-week exercise program on cardiovascular (CV) function.

OUTLINE:

Patients undergo aerobic exercise sessions consisting of cycling or walking at a low-moderate
intensity and progressing to moderate intensity for 30 minutes 2 times a week for up to 8
weeks.

After completion of study treatment, patients are followed up for 6 weeks and at weeks 13,
19, and 31.

Inclusion Criteria:

- Newly diagnosed metastatic (stage IV) colorectal cancer

- Undergoing chemotherapy (have had 1 or 2 chemotherapy cycles infused at time of data
collection; this will allow for any systemic inflammatory changes due to chemotherapy
to set in); only patients with 1st or 2nd line therapy will be included

- Able to initiate a supervised exercise program (free from any CV, respiratory or
musculoskeletal disease or joint problems that preclude moderate physical activity)

- Free from uncontrolled chronic disease including diabetes, hypertension, or thyroid
disease

- Currently participate in less than 60 minutes of physical activity/week

- Willing to travel to the exercise facility at University of Southern California (USC)
(parking fees and public transportation permits will be provided)

- Speak English or Spanish

Exclusion Criteria:

- 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 exercise

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Patients must not be pregnant or nursing due to the potential for congenital
abnormalities and the potential of this regimen to harm nursing infants