Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:19 AM
Study NCT ID:
NCT07472803
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Body Composition Assessment in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D008209', 'term': 'Lymphedema'}], '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'}, {'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'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Skeletal Muscle Mass Index (SMI)', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': "Skeletal Muscle Mass Index (SMI) is the primary metric for assessing muscle mass. It is a composite value calculated by dividing total skeletal muscle mass (kg), as measured by multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare), by the square of the participant's height (m2). Weight and height are measured at each time point to calculate this single aggregated value (kg/m2). Higher scores indicate greater muscle mass relative to height (better outcome).Unit of Measure: kg/m2"}], 'secondaryOutcomes': [{'measure': 'Functional Battery: Change from Baseline in Handgrip Strength', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'Handgrip strength of the dominant hand is measured using a hydraulic dynamometer (LiTE - 200 lb Capacity, USA). Participants perform three trials with a 1-minute rest between attempts; the highest (peak) value of the three trials is recorded. Higher scores indicate greater upper extremity muscle strength (better outcome). Unit of Measure: Kilograms (kg)'}, {'measure': 'Functional Battery: Change from Baseline in 4-Meter Gait Speed', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'The 4-meter gait speed (m/s) is measured using a standardized timed walk test. Participants are instructed to walk at their usual pace for 4 meters from a standing start. The time is recorded in seconds and converted to meters per second (m/s). Higher scores indicate faster walking speed (better outcome). Unit of Measure: Meters per second (m/s)'}, {'measure': 'Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'Functional mobility and balance are measured using the Timed Up \\& Go (TUG) test. The time it takes for a participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down is recorded. Higher scores (longer time taken) indicate poorer functional mobility and balance (worse outcome). Unit of Measure: Seconds'}, {'measure': 'Functional Battery: Change from Baseline in 30-Second Chair Stand Test', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'Lower extremity functional strength is measured as the total number of stands completed in 30 seconds. Participants begin seated and are instructed to stand up and sit down as many times as possible within the 30-second window while keeping their arms crossed over their chest. Higher scores (more stands completed) indicate better lower extremity functional strength and endurance (better outcome). Unit of Measure: Number of stands'}, {'measure': 'Body Composition: Change from Baseline in Body Fat Mass', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'Body fat mass (kg) measured using bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Higher scores indicate greater absolute body fat (worse outcome).'}, {'measure': 'Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'The ratio of total arm lean soft tissue (kg) to total leg lean soft tissue (kg) derived from segmental bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). This ratio is calculated by dividing the sum of lean mass in both arms by the sum of lean mass in both legs. Higher scores indicate a greater proportion of upper limb lean mass relative to lower limb lean mass. Unit of Measure: Ratio'}, {'measure': 'Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'The ratio of total limb lean soft tissue (kg) to trunk lean soft tissue (kg) derived from segmental bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). This ratio is calculated by dividing the sum of lean soft tissue from all four limbs by the lean soft tissue of the trunk. Higher scores indicate a greater proportion of appendicular muscle mass relative to the trunk (better outcome). Unit of Measure: Ratio.'}, {'measure': 'Change from Baseline in Overall Edema Index', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'The Overall Edema Index is calculated as the ratio of Extracellular Water (ECW) to Total Body Water (TBW), as measured by multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). This index evaluates systemic fluid distribution and edema progression. Higher scores indicate a higher level of extracellular fluid relative to total body water (worse outcome).'}, {'measure': 'Change from Baseline in Extracellular Water (ECW)', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'Extracellular Water (ECW) measured in liters via multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Unit of Measure: Liters.'}, {'measure': 'Change from Baseline in Intracellular Water (ICW)', 'timeFrame': 'Baseline, within 2 weeks after final chemotherapy cycle, within 2 weeks after final radiotherapy session, and 6 months following surgery.', 'description': 'Intracellular Water (ICW) measured in liters via multifrequency bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare). Unit of Measure: Liters.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer Survivors', 'Post-Treatment Recovery', 'Body Composition', 'Longitudinal Cohort Study', 'Skeletal Muscle Mass Index', 'Metabolic Monitoring', 'sarcopenia'], 'conditions': ['Breast Neoplasms', 'Body Composition', 'Sarcopenia', 'Fat Redistribution', 'Lymphedema']}, 'descriptionModule': {'briefSummary': 'This observational cohort study aims to track longitudinal changes in body composition, including skeletal muscle mass and fat distribution, in patients diagnosed with breast cancer. Following primary surgery and adjuvant therapy, participants will be monitored over a 2-year period.\n\nThe primary objective is to evaluate the natural progression of skeletal muscle mass index (SMI) and metabolic changes in this population. By conducting serial measurements, this study seeks to characterize the longitudinal trends in muscle loss and body composition shifts post-treatment, providing data to better understand the physiological impact of the cancer recovery process.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients with histologically confirmed primary breast cancer (Stage I-III) recruited from the Department of Breast Surgery/Oncology at the Taipei Buddhist Tzu Chi Hospital. The population includes individuals who have undergone surgical resection and are eligible for, currently receiving, or have recently completed adjuvant therapy (chemotherapy and/or radiotherapy). Patients are tracked through their post-surgical recovery and adjuvant treatment pathways', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years of age\n* Diagnosed with stage I-III non-metastatic breast cancer within 12 months of diagnosis\n* Scheduled for surgery, chemotherapy, with or without radiotherapy or targeted therapy.\n\nExclusion Criteria:\n\n* Women diagnosed with metastatic (stage IV) breast cancer\n* Women planning to move away from the area or be away for more than 6 months during the study period\n* Women planning to become pregnant during the study period\n* Implantable devices (e.g., pacemaker, nerve stimulator) or surgical implants (e.g., total hip or knee replacements)'}, 'identificationModule': {'nctId': 'NCT07472803', 'briefTitle': 'Longitudinal Body Composition Assessment in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation'}, 'officialTitle': 'Long-term Evaluation of the Body Composition and the Impact of Resistance and Relaxation Exercise on Muscle Mass and Quality of Life in Patients With Breast Cancer', 'orgStudyIdInfo': {'id': '13-IRB110-OBS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer Post-Surgical Cohort', 'description': 'Patients with histologically confirmed Stage I-III non-metastatic breast cancer who have undergone primary surgery and are scheduled to undergo or have completed adjuvant therapy (chemotherapy and/or radiotherapy).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '231', 'city': 'New Taipei City', 'state': 'Xindian Dist', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Taipei Tzu Chi Hospital', 'role': 'CONTACT', 'email': 'xdirb@tzuchi.com.tw', 'phone': '+886266289779', 'phoneExt': '5706'}], 'facility': 'Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Valeria Chiu, Attending Physician', 'role': 'CONTACT', 'email': 'haydenbell28@gmail.com', 'phone': '+886266289779', 'phoneExt': '67702'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'De-identified individual participant data that underlie the results reported in this article will be available to researchers who provide a methodologically sound proposal. Proposals may be submitted beginning 9 months and ending 36 months following article publication to the corresponding author. Data will be shared after approval of the proposal and the signing of a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}