Pedaling at a Low-Moderate Intensity During Chemotherapy Administration

September 27, 2024 updated by: Rush University Medical Center

Evaluating the Feasibility of Pedaling at a Low-moderate Intensity During Chemotherapy Infusions in Colorectal Cancer Patients.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Pedaling
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12-24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
12-24 weeks
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.
12-24 weeks
Hospital Admission Rates
Time Frame: 12-24 weeks
The number of hospital admissions during chemotherapy timeframe will be evaluated.
12-24 weeks
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.
12-24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rush University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dana M Hayden, MD, Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19101113

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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