Stage IV Colorectal Cancer
Conditions
Brief summary
This pilot clinical trial studies how well aerobic exercise works in improving quality of life and health-related outcomes in patients with stage IV colorectal cancer undergoing chemotherapy. Aerobic exercise during chemotherapy may improve quality of life and reduce fatigue and inflammation in the blood related to heart disease and diabetes in patients with stage IV colorectal cancer.
Detailed description
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.
Interventions
BEHAVIORALExercise Intervention
Undergo aerobic exercise sessions
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed | Up to 6 weeks | The study will assess the feasibility using average weekly minutes of exercise completion (minutes/week) of all participants. Feasibility will be determined based on the total number of minutes exercised per week with \>80% total weekly minutes (48/60 minutes) completed deeming this trial as feasible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in biomarkers of systemic inflammation | Baseline up to 31 weeks | Change in biomarkers will be examined by a paired sample t-test, with a level of significance set at p \<0.05. |
| Change in cancer-related fatigue | Baseline up to 31 weeks | Assessed by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale |
| Change in QOL | Baseline up to 31 weeks | Assessed by the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in arterial stiffness/geometry | Baseline up to 31 weeks | Assessed by ultrasound |
| Change in endothelial function | Baseline up to 31 weeks | Assessed by flow-mediated dilation |
Countries
United States
Outcome results
None listed