Back to resultsPedaling at a Low-Moderate Intensity During Chemotherapy Administration
Primary Purpose
Colorectal Cancer, Exercise, Aerobic, Chemotherapy
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pedaling
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Pedaling, Sarcopenia, Quality of Life
Eligibility Criteria
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).
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pedaling Group
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Hospital Admission Rates
The number of hospital admissions during chemotherapy timeframe will be evaluated.
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.
Full Information
NCT ID
NCT04258969
First Posted
February 5, 2020
Last Updated
June 7, 2023
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04258969
Brief Title
Pedaling at a Low-Moderate Intensity During Chemotherapy Administration
Official Title
Evaluating the Feasibility of Pedaling at a Low-moderate Intensity During Chemotherapy Infusions in Colorectal Cancer Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
lack of resources
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Exercise, Aerobic, Chemotherapy, Chemotherapeutic Toxicity
Keywords
Pedaling, Sarcopenia, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pedaling Group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Pedaling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Pedaling Concurrent to Chemotherapy Infusion
Description
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 Outcome Measure Information:
Title
Quality of Life Scores
Description
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
Title
Sarcopenia Rates
Description
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
Title
Hospital Admission Rates
Description
The number of hospital admissions during chemotherapy timeframe will be evaluated.
Time Frame
12-24 weeks
Title
Symptom Severity
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana M Hayden, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pedaling at a Low-Moderate Intensity During Chemotherapy Administration
We'll reach out to this number within 24 hrs