Pedaling at a Low-Moderate Intensity During Chemotherapy Administration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04258969|
Recruitment Status : Enrolling by invitation
First Posted : February 6, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Exercise, Aerobic Chemotherapy Chemotherapeutic Toxicity||Behavioral: Pedaling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Feasibility of Pedaling at a Low-moderate Intensity During Chemotherapy Infusions in Colorectal Cancer Patients.|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Pedaling Group
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.
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.
- Feasibility of Pedaling Concurrent to Chemotherapy Infusion [ Time Frame: 12-24 weeks ]The number of completed pedaling sessions as well as the ability of patients to meet goal pedaling intensities will be evaluated.
- Quality of Life Scores [ Time Frame: 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 [ Time Frame: 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.
- Hospital Admission Rates [ Time Frame: 12-24 weeks ]The number of hospital admissions during chemotherapy timeframe will be evaluated.
- Symptom Severity [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258969
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Dana M Hayden, MD||Rush University Medical Center|