Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT04638712
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2020-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
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': 'D001823', 'term': 'Body Composition'}, {'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vastus lateralis cross-sectional area', 'timeFrame': 'Between Week 18 and 24 after chemotherapy', 'description': 'Measured from muscle microbiopsy sample'}], 'secondaryOutcomes': [{'measure': 'Alteration of patients body composition', 'timeFrame': 'Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)', 'description': 'Assessment using bio-impedance analysis'}, {'measure': 'Alteration of patients strength', 'timeFrame': 'Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)', 'description': 'Assessment of maximal isometric muscle strength for knee extensors measured with force sensors.'}, {'measure': 'Alteration of patients muscle architecture', 'timeFrame': 'Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)', 'description': 'Assessment using muscle ultrasonography'}, {'measure': 'Alteration of patients quality of life', 'timeFrame': 'Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)', 'description': 'Self-assessment questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) (version 3)'}, {'measure': 'Evaluation of patient cachexia', 'timeFrame': 'Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)', 'description': 'Questionnaire Functional Assessment of Anorexia/Cachexia Therapy (FAACT) (version 4)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34595171', 'type': 'RESULT', 'citation': 'Mallard J, Hucteau E, Hureau TJ, Pagano AF. Skeletal Muscle Deconditioning in Breast Cancer Patients Undergoing Chemotherapy: Current Knowledge and Insights From Other Cancers. Front Cell Dev Biol. 2021 Sep 14;9:719643. doi: 10.3389/fcell.2021.719643. eCollection 2021.'}, {'pmid': '35373507', 'type': 'RESULT', 'citation': 'Mallard J, Hucteau E, Charles AL, Bender L, Baeza C, Pelissie M, Trensz P, Pflumio C, Kalish-Weindling M, Geny B, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Chemotherapy impairs skeletal muscle mitochondrial homeostasis in early breast cancer patients. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1896-1907. doi: 10.1002/jcsm.12991. Epub 2022 Apr 4.'}, {'pmid': '36094434', 'type': 'RESULT', 'citation': 'Mallard J, Hucteau E, Bender L, Charlot A, Debrut L, Pflumio C, Trensz P, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Development of skeletal muscle atrophy and intermuscular adipose tissue in patients with early breast cancer treated with chemotherapy. Am J Physiol Cell Physiol. 2022 Oct 1;323(4):C1325-C1332. doi: 10.1152/ajpcell.00373.2022. Epub 2022 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'This is an interventional, prospective and monocentric study. This study includes the evaluation before and after (neo)adjuvant therapy of :\n\n* one group of patients receiving anthracyclines and taxanes\n* a second group of patients receiving anthracyclines, taxanes and trastuzumab.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor group 1 without trastuzumab :\n\n* Patients must be ≥ 18 years old\n* Patients with breast cancer stage I to III\n* Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, without trastuzumab\n* Patients must have a social security coverage\n* Patients able to speak, read and understand French\n\nFor group 2 with trastuzumab :\n\n* Patients must be ≥ 18 years old\n* Patients with breast cancer grade I to III\n* Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, with trastuzumab\n* Patients must have a social security coverage\n* Patients able to speak, read and understand French\n\nExclusion Criteria:\n\n* History of cancer\n* Previous chemotherapy\n* Patients with known chronic pathology (musculoskeletal disorders, autoimmune, vascular or neuromuscular disease)\n* Pacemaker implantation\n* Contraindication to physical condition evaluation\n* Contraindication to local anesthesia required for microbiopsy\n* Patients \\< 18 years old or patients ≥ 18 years old under guardianship, or supervision\n* Psychiatric, musculoskeletal or neurologic disorders\n* Women that are pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT04638712', 'acronym': 'PROTECT-03', 'briefTitle': 'Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institut de cancérologie Strasbourg Europe'}, 'officialTitle': 'Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients', 'orgStudyIdInfo': {'id': '2020-006'}, 'secondaryIdInfos': [{'id': '2020-A01266-33', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1 without trastuzumab', 'interventionNames': ['Other: Microbiopsy sample', 'Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level']}, {'type': 'OTHER', 'label': 'Group 2 with trastuzumab', 'interventionNames': ['Other: Microbiopsy sample', 'Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level']}], 'interventions': [{'name': 'Microbiopsy sample', 'type': 'OTHER', 'description': 'before and after chemotherapy', 'armGroupLabels': ['Group 1 without trastuzumab', 'Group 2 with trastuzumab']}, {'name': 'Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level', 'type': 'OTHER', 'description': 'before and after chemotherapy', 'armGroupLabels': ['Group 1 without trastuzumab', 'Group 2 with trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67033', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Institut de Cancerologie Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de cancérologie Strasbourg Europe', 'class': 'OTHER'}, 'collaborators': [{'name': 'UR 3072 - Mitochondries, Stress oxydant, Protection musculaire', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}