Exercise Program During Chemotherapy in Metastatic Colorectal Cancer
NCT ID: NCT03111823
Last Updated: 2018-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2016-07-07
2018-07-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive Care (aerobic exercise)
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.
Exercise Intervention
Undergo aerobic exercise sessions
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Exercise Intervention
Undergo aerobic exercise sessions
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Christina Dieli-Conwright, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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3C-16-1
Identifier Type: -
Identifier Source: org_study_id
NCI-2016-01089
Identifier Type: REGISTRY
Identifier Source: secondary_id
3C-16-1
Identifier Type: OTHER
Identifier Source: secondary_id
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