Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-28 @ 10:41 AM
Study NCT ID:
NCT04013568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-10
First Post:
2019-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Post-Diagnosis of 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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants choose the initial intervention (12-week exercise program (Group1) vs monitoring (Group2)).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2019-06-14', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat mass', 'timeFrame': '1 day', 'description': 'Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data'}, {'measure': 'Isometric peak torque', 'timeFrame': '1 day', 'description': 'Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device'}, {'measure': 'Lean mass', 'timeFrame': '1 day', 'description': 'Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data'}, {'measure': 'Bone mass', 'timeFrame': '1 day', 'description': 'Measure bone mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data'}, {'measure': 'Waist to Hip ratio (WHR) from manual tape measurement', 'timeFrame': '1 day', 'description': 'Manual physical anthropometry of waist and hip circumferences'}, {'measure': 'Automatic 3D optical (3DO) scan measurement: girth measurement', 'timeFrame': '1 day', 'description': 'Automated 3DO measurements generate the following: girth in cm measurements across the whole body'}, {'measure': 'Muscle Function', 'timeFrame': '1 day', 'description': 'Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device'}, {'measure': 'Percent fat', 'timeFrame': '1 day', 'description': 'Percent fat (arms, legs, trunk and total) using Dual energy X-ray absorptiometry (DXA) data'}, {'measure': 'Automatic 3D optical (3DO) scan measurement: length measurement', 'timeFrame': '1 day', 'description': 'Automated 3DO measurements generate the following: length in cm measurements across the whole body'}, {'measure': 'Automatic 3D optical (3DO) scan measurement: volume measurement', 'timeFrame': '1 day', 'description': 'Automated 3DO measurements generate the following: volume in cm measurements across the whole body'}, {'measure': 'Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data', 'timeFrame': '1 day', 'description': 'Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data'}], 'secondaryOutcomes': [{'measure': 'Recurrence Free Survival', 'timeFrame': '5 years', 'description': 'obtained from last physician note'}, {'measure': 'BIBCQ-Body Image After Breast Cancer questionnaire', 'timeFrame': '5 years', 'description': '45 items'}, {'measure': 'BFI-Brief Fatigue Innovatory questionnaire', 'timeFrame': '5 years', 'description': '9 items'}, {'measure': 'PHQ-9- Patient Health (Depression) questionnaire', 'timeFrame': '5 years', 'description': '9 items'}, {'measure': 'FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire', 'timeFrame': '5 years', 'description': '27 items'}, {'measure': 'Diet History Questionnaire II', 'timeFrame': '5 years', 'description': 'Self-reported energy intake, measured as kcal/day'}, {'measure': 'Biomarkers', 'timeFrame': '5 years', 'description': 'Adipokines: leptin, HMW-high molecular weight adiponectin, PAI1-plasminogen activator inhibitor\n\nCytokines \\& Inflammation: TNF-tumor necrosis factor α, IL-interleukin 1β, IL2, IL4, IL5, IL6, IL8, IL10, interferon, CRP-C reactive protein, uric acid, cortisol\n\nInsulin Resistance \\& IGFs: glucose, insulin, Hb-hemoglobin A1C, IGF-insulin growth factor 1, IGFBP-insulin like growth factor binding protein 1-3\n\nSex Steroid Hormones: total estradiol \\& estrone, total testosterone, SHBG-sex hormone-binding globulin (for free estradiol and free testosterone will be derived)\n\nLipid Profile \\& Lipid-soluble Micronutrients: TG-triglycerides , total cholesterol, HDLC-high density lipoprotein cholesterol , free fatty acids, lycopene, 25OH-vitamin D3, alpha-tocopherol\n\nLiver Enzymes: ALT-alanine aminotransferase\n\nNeuropeptides \\& Gut Hormones: ghrelin\n\nMOTS-mitochondrial derived peptide-c'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.', 'detailedDescription': "The study is enrolling breast cancer patients up to 2 years after their diagnosis in a 12-week exercise program. The participants will either participate in: Group 1-participating in an exercise program with biometric evaluations or Group 2-biometric evaluations but not participating in the exercise program. At the end of the 12-week exercise program, participants in Group 1 will be randomized to either: a) continuing with exercise group classes or b) continuing with exercise individual classes. Both Group 1a and 1b participants will be followed for the remainder of the year and be evaluated for continued physical activity. All Group study participants' biometrics will be assessed at baseline and at the end of 12-weeks, with continued annual medical review follow-up for a total of 5 years."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New diagnosis of breast cancer (within the past 2 years, any subtype, stage I-III)\n* Can be undergoing neo/adjuvant treatment (surgery, chemotherapy, radiation or endocrine therapy)\n* Participant is willing and able to comply with the protocol for the duration of the study including undergoing scheduled exercise sessions, completing questionnaires and biometric/biomarker studies\n* Participant must be able to lie flat on their back for up to 10 minutes\n* Participant must be able to stand without aid for at least 2 minutes\n\nExclusion Criteria:\n\n* Participant with breast cancer recurrence\n* Metastatic breast cancer\n* Uncontrolled psychiatric disorder that can affect self-assessment\n* Pregnant patient\n* Participants with any internal artifact (e.g. pacemakers, internal fixation, arthroplasty) or other physical impairment that would alter the body composition assessment'}, 'identificationModule': {'nctId': 'NCT04013568', 'briefTitle': 'Exercise Post-Diagnosis of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Hawaii'}, 'officialTitle': 'A Pilot Study: The Effect of Longitudinal Exercise Programming in Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'Fukui-2019-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 - Agree to Exercise Program', 'description': '12-week exercise program', 'interventionNames': ['Other: Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2 - Declines Exercise Program', 'description': 'Same biometric and biomarker assessment at as Group 1 (at baseline, after 12 weeks and annually) however they will not participate in the exercise sessions'}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'First Intervention 12-week exercise program, 3 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Private or semi-private (1:1 or 2:1 ratio participant to instructor) sessions, led by Kinesiology students\n\nSecond Intervention- 12-week exercise program, 2 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Group Fitness Classes', 'armGroupLabels': ['Group 1 - Agree to Exercise Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'University of Hawaii Cancer Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], 'overallOfficials': [{'name': 'Jami Fukui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hawaii Cancer Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hawaii', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rehabilitation Hospital of the Pacific', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}