Pedaling at a Low-Moderate Intensity During Chemotherapy Administration

Rush

Status: Withdrawn

Conditions: Chemotherapy; Chemotherapeutic Toxicity; Exercise, Aerobic; Colorectal Cancer

Treatments: Behavioral: Pedaling

Study type: Interventional

Funder types: Other

Identifiers

NCT04258969

19101113

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Pedaling Group

Experimental 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.

Treatment:

Behavioral: Pedaling