Pedaling at a Low-Moderate Intensity During Chemotherapy Administration

Not Applicable

Withdrawn

• Conditions: Colorectal Cancer; Exercise, Aerobic; Chemotherapeutic Toxicity; Chemotherapy
• Interventions: Behavioral: Pedaling

• Registration Number: NCT04258969
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-11
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Primary Completion: 2021-10-14
• Study Completion: 2021-10-14
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pedaling Group	Pedaling	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hospital Admission Rates	12-24 weeks	The number of hospital admissions during chemotherapy timeframe will be evaluated.
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.
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.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States