Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-01-09 @ 12:34 PM
Study NCT ID:
NCT03102866
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2017-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-31', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot)', 'timeFrame': 'Up to 1 year', 'description': 'determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program.'}, {'measure': 'Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II)', 'timeFrame': 'At 1 year', 'description': 'Will be compared to usual care group.'}], 'secondaryOutcomes': [{'measure': 'Arm lymphedema as measured by arm circumference', 'timeFrame': 'Baseline up to 1 year', 'description': 'Lymphedema will be classified into 3 stages. Stage I edema is reversible and characterized by pitting edema, increase in arm girth, and heaviness. Stage II is characterized by a spongy consistency of the arm without pitting edema. Stage III is the most advanced stage, lymphostatic elephantiasis'}, {'measure': 'Arm range of motion as measured by goniometry', 'timeFrame': 'Baseline up to 1 year', 'description': 'Shoulder flexion, external and internal rotation, and abduction will be measured.'}, {'measure': 'Change in weight and BMI', 'timeFrame': 'Baseline up to 1 year', 'description': 'BMI will be measured to evaluate body composition using the metric formula weight (kg)/ height 2 (m2).'}, {'measure': 'Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs', 'timeFrame': 'Baseline up to 1 year', 'description': 'Duration of exercise will be calculated based on questionnaire and exercise log. Percentage of exercise adherence at 1-year follow-up will be compared between two groups. Generalized linear models will be utilized to model follow-up as a function of baseline and group.'}, {'measure': 'Percent increase in arm strength as measured by one repetition maximum', 'timeFrame': 'Baseline up to 1 year', 'description': 'Change in strength from baseline to post-intervention and follow-up will be obtained.'}, {'measure': 'Quality of life as measured by FACT-B+4', 'timeFrame': 'Baseline up to 1 year', 'description': 'The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales (0 - 4) for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms.'}, {'measure': 'Subjective arm health as measured by FACT-B+4', 'timeFrame': 'Baseline up to 1 year', 'description': 'The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales (0 - 4) for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage II Breast Cancer', 'Stage IIA Breast Cancer', 'Stage IIB Breast Cancer', 'Stage III Breast Cancer', 'Stage IIIA Breast Cancer', 'Stage IIIB Breast Cancer', 'Stage IIIC Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. (Pilot) II. To determine the percent increase in fitness as measured by the 6 minute walk test in women receiving radiation therapy for breast cancer randomized to an exercise program at 1 year. (Phase II)\n\nSECONDARY OBJECTIVES:\n\nI. Percent adherence to exercise at 1 year as measured by the International Physical Activity Questionnaire and exercise logs.\n\nII. Subjective arm health at 1 year as measured by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4).\n\nIII. Arm lymphedema at 1 year as measured by arm circumference. IV. Arm range of motion at 1 year as measured by goniometry. V. Quality of life at 1 year as measured by FACT-B+4. VI. Percent increase in arm strength as measured by one repetition maximum at 1 year.\n\nVII. Change in weight and body mass index (BMI) 1 year after completion of radiation.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.\n\nARM II: Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.\n\nAfter completion of study, patients are followed up at 1 year.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage II-III breast cancer\n* Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection\n* Prior chemotherapy in the neoadjuvant or adjuvant setting\n* Radiation plan consisting of regional nodal radiation\n* Must be suitable for an exercise program\n\nExclusion Criteria:\n\n* Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician\n* Physical handicap that would prevent participation in program\n* Patients with metastatic breast cancer'}, 'identificationModule': {'nctId': 'NCT03102866', 'briefTitle': 'Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Can Aerobic and Strength Training Exercise Initiated During and Continued After Radiation Therapy for Breast Cancer Improve Fitness and Arm Health 1 Year Later?', 'orgStudyIdInfo': {'id': 'OSU-16125'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00318', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (usual care)', 'description': 'Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.', 'interventionNames': ['Other: Best Practice', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (aerobic and strength training exercise)', 'description': 'Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.', 'interventionNames': ['Behavioral: Exercise Intervention', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive usual care', 'armGroupLabels': ['Arm I (usual care)']}, {'name': 'Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Undergo aerobic and strength training exercise', 'armGroupLabels': ['Arm II (aerobic and strength training exercise)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (usual care)', 'Arm II (aerobic and strength training exercise)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (usual care)', 'Arm II (aerobic and strength training exercise)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Sasha Beyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sasha Beyer', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}