Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-23 @ 7:14 AM
Study NCT ID:
NCT02739620
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2016-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors
Sponsor:
Organization:
Raw JSON
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Toth', 'organization': 'University of Vermont'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Our study was powered to detect effects on skeletal muscle at the cellular level over a short time period during treatment.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'NMES', 'description': 'Neuromuscular electrical stimulation (NMES) group\n\nNeuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Control group', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Febrile episode', 'notes': 'Patient became febrile during testing. Adjudicated to be moderate severity, unexpected and not related to study participation/intevention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization', 'notes': 'Hospitalization for pyelonephritis. Adjudicated to be severe, unexpected and not related to study participation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximal Calcium-activated Tension Single Muscle Fiber Tension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NMES', 'description': 'Neuromuscular electrical stimulation (NMES) group\n\nNeuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control group'}], 'classes': [{'title': 'Baseline testing', 'categories': [{'measurements': [{'value': '185', 'spread': '10', 'groupId': 'OG000'}, {'value': '172', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention testing', 'categories': [{'measurements': [{'value': '172', 'spread': '9', 'groupId': 'OG000'}, {'value': '168', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Difference between values at baseline at 2 months', 'description': 'Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis', 'unitOfMeasure': 'milliNewtons per millimeter^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing.'}, {'type': 'PRIMARY', 'title': 'Cross-sectional Area of Skeletal Muscle Fibers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NMES', 'description': 'Neuromuscular electrical stimulation (NMES) group\n\nNeuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control group'}], 'classes': [{'title': 'Baseline testing', 'categories': [{'measurements': [{'value': '2432', 'spread': '246', 'groupId': 'OG000'}, {'value': '2320', 'spread': '261', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention testing', 'categories': [{'measurements': [{'value': '2694', 'spread': '246', 'groupId': 'OG000'}, {'value': '2381', 'spread': '260', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Difference between values at baseline at 2 months', 'description': 'Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types', 'unitOfMeasure': 'micrometers^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing.'}, {'type': 'PRIMARY', 'title': 'Intermyofibrillar Mitochondrial Content', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NMES', 'description': 'Neuromuscular electrical stimulation (NMES) group\n\nNeuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control group'}], 'classes': [{'title': 'Baseline testing', 'categories': [{'measurements': [{'value': '2.72', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention testing', 'categories': [{'measurements': [{'value': '2.75', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Difference between values at baseline at 2 months', 'description': 'Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy', 'unitOfMeasure': 'percentage of image area', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing and the fact that electron microscopy measures could not be completed on one volunteer because of insufficient muscle tissue.'}, {'type': 'SECONDARY', 'title': 'Single Muscle Fiber Contractile Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NMES', 'description': 'Neuromuscular electrical stimulation (NMES) group\n\nNeuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control group'}], 'classes': [{'title': 'Baseline testing', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention testing', 'categories': [{'measurements': [{'value': '1.92', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Difference between values at baseline at 2 months', 'description': 'Single muscle fiber contractile velocity assessed using isotonic load clamps, with muscle fiber type determined post-measurement by gel electrophoresis. The velocity of contraction is expressed relative to the length of the muscle fiber segment evaluated (as measured using a eyepiece micrometer during assessments) per second.', 'unitOfMeasure': 'muscle lengths per second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample sizes reflect the number of volunteers with paired data at both baseline and 2-month testing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NMES', 'description': 'Neuromuscular electrical stimulation (NMES) group\n\nNeuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Baseline Testing', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Intervention Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Post-intervention Testing', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NMES', 'description': 'Neuromuscular electrical stimulation (NMES) group\n\nNeuromuscular electrical stimulation: Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '54.5', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '71.2', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '73.2', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.4', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '161.6', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '162.6', 'spread': '8.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percentage of body fat', 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '7', 'groupId': 'BG000'}, {'value': '39.9', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '6.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fat mass', 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '28.3', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '30.2', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fat-free mass', 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '41.3', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '41.4', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Appendicular skeletal muscle mass', 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '24.7', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '25.0', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-15', 'size': 322394, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-12T06:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2016-04-08', 'resultsFirstSubmitDate': '2023-02-12', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-13', 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Calcium-activated Tension Single Muscle Fiber Tension', 'timeFrame': 'Difference between values at baseline at 2 months', 'description': 'Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis'}, {'measure': 'Cross-sectional Area of Skeletal Muscle Fibers', 'timeFrame': 'Difference between values at baseline at 2 months', 'description': 'Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types'}, {'measure': 'Intermyofibrillar Mitochondrial Content', 'timeFrame': 'Difference between values at baseline at 2 months', 'description': 'Area fraction of intermyofibrillar mitochondria will be assessed by electron microscopy'}], 'secondaryOutcomes': [{'measure': 'Single Muscle Fiber Contractile Velocity', 'timeFrame': 'Difference between values at baseline at 2 months', 'description': 'Single muscle fiber contractile velocity assessed using isotonic load clamps, with muscle fiber type determined post-measurement by gel electrophoresis. The velocity of contraction is expressed relative to the length of the muscle fiber segment evaluated (as measured using a eyepiece micrometer during assessments) per second.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Exercise training has beneficial effects in cancer survivors to minimize some of the side effects of cancer and its treatment and improve long-term prognosis, but there are numerous hurdles for individuals diagnosed with, and being treated for, cancer to participate in exercise programs. The goal of this research study is to begin to evaluate whether exercise training via neuromuscular electrical stimulation (NMES) has beneficial effects on skeletal muscle size and function in cancer survivors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. stage I, II or III breast cancer\n2. receiving neoadjuvant or adjuvant chemotherapy with or without radiation\n3. a body mass index \\<35 kg/m2.\n\nExclusion Criteria:\n\n1. metastatic disease, a prior history of cancer, excluding non-melanoma skin cancer, or prior receipt of chemotherapy\n2. autoimmune, vascular or neuromuscular disease that could alter skeletal muscle\n3. prior knee or hip replacement\n4. contraindications for use of neuromuscular electrical stimulation, including an implanted cardiac defibrillator or pacemaker, lower extremity blood clot or coagulopathy\n5. pregnancy'}, 'identificationModule': {'nctId': 'NCT02739620', 'briefTitle': 'Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Alternative Exercise Program to Improve Skeletal Muscle Function and Fatigue in Cancer Survivors', 'orgStudyIdInfo': {'id': 'M16-333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NMES', 'description': 'Neuromuscular electrical stimulation (NMES) group', 'interventionNames': ['Device: Neuromuscular electrical stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group'}], 'interventions': [{'name': 'Neuromuscular electrical stimulation', 'type': 'DEVICE', 'description': 'Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.', 'armGroupLabels': ['NMES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont College of Medicine', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Michael J Toth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Michael J. Toth, Ph.D.', 'investigatorAffiliation': 'University of Vermont'}}}}