Study Stopped
Insufficient Accrual
Exercise Program During Chemotherapy in Metastatic Colorectal Cancer
Feasibility of a 6-Week Aerobic Exercise Program During Chemotherapy for Metastatic Colorectal Cancer
3 other identifiers
interventional
2
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2016
CompletedFirst Submitted
Initial submission to the registry
July 29, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2018
CompletedAugust 13, 2018
August 1, 2018
2 years
July 29, 2016
August 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed
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.
Up to 6 weeks
Secondary Outcomes (3)
Change in biomarkers of systemic inflammation
Baseline up to 31 weeks
Change in cancer-related fatigue
Baseline up to 31 weeks
Change in QOL
Baseline up to 31 weeks
Other Outcomes (2)
Change in arterial stiffness/geometry
Baseline up to 31 weeks
Change in endothelial function
Baseline up to 31 weeks
Study Arms (1)
Supportive Care (aerobic exercise)
EXPERIMENTALPatients 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.
Interventions
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Dieli-Conwright, Ph.D.
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2016
First Posted
April 13, 2017
Study Start
July 7, 2016
Primary Completion
July 5, 2018
Study Completion
July 5, 2018
Last Updated
August 13, 2018
Record last verified: 2018-08