Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-29 @ 12:48 AM
Study NCT ID:
NCT00869804
Status:
TERMINATED
Last Update Posted:
2023-12-05
First Post:
2009-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heading Off Peripheral Neuropathy With Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Could not recruit total numbers needed. PI left institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2011-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2009-03-25', 'studyFirstSubmitQcDate': '2009-03-25', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect size for reduction of neuropathic symptoms', 'timeFrame': 'Baseline, 4, 8 12, 24 weeks', 'description': 'effect size for reduction of neuropathic symptoms'}], 'secondaryOutcomes': [{'measure': 'effect size for potential covariates on measures of chemotherapy-induced peripheral neuropathy', 'timeFrame': 'Baseline, 4, 8, 12, 24 weeks', 'description': 'effect size for potential covariates (age, taxane dose, baseline level of exercise participation, breast cancer-related symptoms) on measures of chemotherapy-induced peripheral neuropathy'}, {'measure': 'feasibility and acceptability of a home-based aerobic and strength training exercise program', 'timeFrame': 'Baseline, 4, 8, 12, 24 weeks', 'description': 'determine the feasibility and acceptability of a home-based aerobic and strength training exercise program during and after taxane-based chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'chemotherapy-induced peripheral neuropathy', 'exercise'], 'conditions': ['Peripheral Nervous System Disorders', 'Breast Neoplasms', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': 'Chemotherapy for the treatment of breast cancer can affect nerves and muscles leading to loss of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle weakness. This study will explore if exercises such as walking and strength training may prove helpful in preventing or lessening chemotherapy-induced peripheral neuropathy from chemotherapy, making the therapy easier to tolerate and increasing overall quality of life.', 'detailedDescription': 'This pilot study will test the effects of a tailored home-based walking (aerobic) and strength training (resistance) exercise program for individuals receiving taxane-based chemotherapy for breast cancer on neuropathy, breast cancer-related symptoms, cold thermal sensation, vibratory sensation, gait \\& balance, upper and lower extremity muscle strength, and quality of life.\n\nThe objective of this pilot study is to determine the effect size, feasibility and acceptability of a 12-week combination exercise program consisting of aerobic exercise (walking) and strength training for preventing or ameliorating the clinical manifestations and symptoms of CIPN in individuals with Stage I-IIIa non-metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 19 or older with newly diagnosed Stage I-IIIa invasive breast cancer who are to be treated with a taxane-based chemotherapy regimen (with paclitaxel or docetaxel) and thus are at risk for the development of CIPN.\n\nExclusion Criteria:\n\n* any disease (e.g. diabetes, HIV) that results in peripheral neuropathy;\n* any disease or disorder that results in muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke, preexisting cardiopulmonary disease);\n* any disease or disorder that would preclude strength training exercises (such as bone metastasis, osteoporosis);\n* individuals with diagnosed lymphedema or advanced disease (\\> Stage IIIa, or metastatic disease) at high risk for bone metastases and pathologic fracture will be excluded.'}, 'identificationModule': {'nctId': 'NCT00869804', 'acronym': 'HOPE', 'briefTitle': 'Heading Off Peripheral Neuropathy With Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Pilot Randomized Study of Aerobic and Resistance Exercise for Women Undergoing Treatment for Breast Cancer With Taxanes.', 'orgStudyIdInfo': {'id': '0478-08-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'combination aerobic (walking) and resistance (strength training) exercise', 'interventionNames': ['Behavioral: Aerobic/ Resistance Exercise Intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'attention control', 'description': 'attention control with daily journal and cancer-related education', 'interventionNames': ['Behavioral: Attention control']}], 'interventions': [{'name': 'Aerobic/ Resistance Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention will consist of a tailored home-based program of both aerobic (walking, using pedometer) and strength training exercises for upper and lower extremities using resistance power bands.', 'armGroupLabels': ['Exercise']}, {'name': 'Attention control', 'type': 'BEHAVIORAL', 'armGroupLabels': ['attention control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Constance Visovsky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}