Clinical trial · Interventional
Pedaling at a Low-Moderate Intensity During Chemotherapy Administration
Evaluating the Feasibility of Pedaling at a Low-moderate Intensity During Chemotherapy Infusions in Colorectal Cancer Patients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of resources
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Exercise, Aerobic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pedaling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pedaling Group
- description
- During the first 2 hours of their chemotherapy infusions, participants will pedaling for 30 minutes using a stationary cycle ergometer. Participants will be allowed to determine their pedaling intensity and cadence, however, will be encouraged to reach the established goal intensity level. Additionally, subjects will complete both a physical activity questionnaire (International Physical Activity Questionnaire) and a quality of life questionnaire (European Organization for Research and Treatment of Cancer QLQ - CR 29) at baseline and following their last chemotherapy treatment. 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. Lastly, muscular strength and physical performance will be measured via grip strength tests and TGUG tests within 2-4 weeks of the post-surgery and chemotherapy completion CT scans.
- interventionNames
- Behavioral: Pedaling
Primary outcomes (1)
- measure
- Feasibility of Pedaling Concurrent to Chemotherapy Infusion
- timeFrame
- 12-24 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
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