Trials / Terminated
TerminatedNCT03111823
Exercise Program During Chemotherapy in Metastatic Colorectal Cancer
Feasibility of a 6-Week Aerobic Exercise Program During Chemotherapy for Metastatic Colorectal Cancer
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Exercise Intervention | Undergo aerobic exercise sessions |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2016-07-07
- Primary completion
- 2018-07-05
- Completion
- 2018-07-05
- First posted
- 2017-04-13
- Last updated
- 2018-08-13
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03111823. Inclusion in this directory is not an endorsement.