Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT04258969
Status:
WITHDRAWN
Last Update Posted:
2024-10-01
First Post:
2020-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pedaling at a Low-Moderate Intensity During Chemotherapy Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of resources', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Pedaling Concurrent to Chemotherapy Infusion', 'timeFrame': '12-24 weeks', 'description': 'The number of completed pedaling sessions as well as the ability of patients to meet goal pedaling intensities will be evaluated.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Scores', 'timeFrame': '12-24 weeks', '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.'}, {'measure': 'Sarcopenia Rates', 'timeFrame': '12-24 weeks', '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."}, {'measure': 'Hospital Admission Rates', 'timeFrame': '12-24 weeks', 'description': 'The number of hospital admissions during chemotherapy timeframe will be evaluated.'}, {'measure': 'Symptom Severity', 'timeFrame': '12-24 weeks', '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pedaling', 'Sarcopenia', 'Quality of Life'], 'conditions': ['Colorectal Cancer', 'Exercise, Aerobic', 'Chemotherapy', 'Chemotherapeutic Toxicity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosed colon or rectal cancer with previous surgical intervention and planned intravenous chemotherapy treatment (FOLFOX or FOLFIRI).\n* ECOG Performance Status of Grade 0-2.\n\nExclusion Criteria:\n\n* Limited functional status, demonstrated by an ECOG Performance Status of Grade 3-5.\n* 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).\n* Chest pain or severe shortness of breath at rest or with physical activity.\n* Orthopedic impediments to exercise (i.e. joint immobility or lower extremity lymphedema).\n* Limitations to sustained exercise (i.e. bone metastases in the femur neck).\n* Severe arthritis (i.e. osteoarthritis or rheumatoid arthritis).'}, 'identificationModule': {'nctId': 'NCT04258969', 'briefTitle': 'Pedaling at a Low-Moderate Intensity During Chemotherapy Administration', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Evaluating the Feasibility of Pedaling at a Low-moderate Intensity During Chemotherapy Infusions in Colorectal Cancer Patients.', 'orgStudyIdInfo': {'id': '19101113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pedaling Group', '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.', 'interventionNames': ['Behavioral: Pedaling']}], 'interventions': [{'name': 'Pedaling', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Pedaling Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Dana M Hayden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}