Pedaling at a Low-Moderate Intensity During Chemotherapy Administration

NCT04258969 | Withdrawn

• 1 other identifier: 19101113
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Exercise, Aerobic; Chemotherapy; Chemotherapeutic Toxicity

Keywords

Pedaling; Sarcopenia; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  12-24 weeks

Secondary Outcomes (4)

• Quality of Life Scores

  12-24 weeks

• Sarcopenia Rates

  12-24 weeks

• Hospital Admission Rates

  12-24 weeks

• Symptom Severity

  12-24 weeks

Study Arms (1)

Pedaling Group

EXPERIMENTAL

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

Interventions

Pedaling BEHAVIORAL

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.

Pedaling Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity; Sarcopenia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Dana M Hayden, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 6, 2020
• Study Start: January 11, 2020
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (1)