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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01089 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 3C-16-1 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (aerobic exercise) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Undergo aerobic exercise sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in biomarkers of systemic inflammation | Change in biomarkers will be examined by a paired sample t-test, with a level of significance set at p <0.05. | Baseline up to 31 weeks |
| Change in cancer-related fatigue |
| Measure | Description | Time Frame |
|---|---|---|
| Change in arterial stiffness/geometry | Assessed by ultrasound | Baseline up to 31 weeks |
| Change in endothelial function | Assessed by flow-mediated dilation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Dieli-Conwright, Ph.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County-USC Medical Center | Los Angeles | California | 90033 | United States | ||
| USC / Norris Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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Assessed by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
| Baseline up to 31 weeks |
| Change in QOL | Assessed by the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C) | Baseline up to 31 weeks |
| Baseline up to 31 weeks |
| Los Angeles |
| California |
| 90033 |
| United States |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |