Chemotherapeutic Toxicity, Chemotherapy, Colorectal Cancer, Exercise, Aerobic
Conditions
Keywords
Pedaling, Sarcopenia, Quality of Life
Brief summary
The purpose of this study is to evaluate the feasibility of completing a low-moderate intensity pedaling session concurrent to chemotherapy treatment for colorectal cancer. Secondary objectives for this study consist of evaluating the role of pedaling on sarcopenia rates, quality of life markers, chemotherapy side effects, rate of hospital admissions, and treatment delays.
Interventions
BEHAVIORALPedaling
Participants will pedaling at a low-moderate intensity using a stationary pedal ergometer concurrent to their chemotherapy (FOLFOX or FOLFIRI) infusion. Participants will cycle for 30 min within the first 2 hours of their infusion.
Sponsors
Rush University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with diagnosed colon or rectal cancer with previous surgical intervention and planned intravenous chemotherapy treatment (FOLFOX or FOLFIRI). * ECOG Performance Status of Grade 0-2.
Exclusion criteria
* Limited functional status, demonstrated by an ECOG Performance Status of Grade 3-5. * Severe cardiac history or comorbidities (i.e. have a cardiac defibrillator or have a history of heart failure, clinically significant aortic stenosis, cardiac arrest, uncontrolled angina, uncontrolled arrhythmias, major heart surgery, stroke, or pulmonary embolus). * Chest pain or severe shortness of breath at rest or with physical activity. * Orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema). * Limitations to sustained exercise (i.e. bone metastases in the femur neck). * Severe arthritis (i.e. osteoarthritis or rheumatoid arthritis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Pedaling Concurrent to Chemotherapy Infusion | 12-24 weeks | The number of completed pedaling sessions as well as the ability of patients to meet goal pedaling intensities will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Scores | 12-24 weeks | Quality of life markers will be assessed using the European Organization for Research and Treatment of Cancer \[EORTC\] QLQ - CR 29 at baseline and following their last chemotherapy treatment. |
| Sarcopenia Rates | 12-24 weeks | The presence of sarcopenia is best defined by evaluating muscle mass, muscle strength, and physical performance. CT scans will be obtained at time of diagnosis (pre-surgery), post-surgery (pre-chemotherapy), and following chemotherapy completion. Patient's CT scans will be uploaded to a medical image analysis software (SliceOmatic) which allows for the evaluation of body composition. Within 2-4 weeks of the post-surgery and chemotherapy completion CT scans, muscular strength and physical performance will be measured via grip strength tests and Timed- Get-Up and Go tests, respectively. |
| Hospital Admission Rates | 12-24 weeks | The number of hospital admissions during chemotherapy timeframe will be evaluated. |
| Symptom Severity | 12-24 weeks | A questionnaire on chemotherapy side effects (Memorial Symptom Assessment Scale) will be gathered at baseline, during chemotherapy cycles 3, 6, and/or 12, and following completion of chemotherapy treatment to measure severity of chemotherapy-related symptoms. |
Countries
United States
Outcome results
None listed