Pedaling at a Low-Moderate Intensity During Chemotherapy Administration

Rush University Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Colorectal Cancer Exercise, Aerobic Chemotherapy Chemotherapeutic Toxicity

Interventions

PedalingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Feasibility of Pedaling Concurrent to Chemotherapy Infusion

The number of completed pedaling sessions as well as the ability of patients to meet goal pedaling intensities will be evaluated.

Time frame: 12-24 weeks

Secondary Outcomes

Quality of Life Scores

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.

Time frame: 12-24 weeks

Sarcopenia Rates

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.

Time frame: 12-24 weeks

Hospital Admission Rates

The number of hospital admissions during chemotherapy timeframe will be evaluated.

Time frame: 12-24 weeks

Symptom Severity

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.

Time frame: 12-24 weeks

Data from ClinicalTrials.gov

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