Clinical trial · Interventional
Exercise Program During Chemotherapy in Metastatic Colorectal Cancer
Feasibility of a 6-Week Aerobic Exercise Program During Chemotherapy for Metastatic Colorectal Cancer
NCT03111823CI-TRIAL-00034301terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient Accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (aerobic exercise)
- description
- 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.
- interventionNames
- Behavioral: Exercise Intervention
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed
- timeFrame
- Up to 6 weeks
- description
- 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 outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.