Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-06 @ 12:52 AM
Study NCT ID:
NCT06536556
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-05
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Single Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: Comparison of Paclitaxel vs Paclitaxel + Trastuzumab vs Paclitaxel + Carboplatine: the PROTECT-06 Bis Study
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'muscle micro-biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-09-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the effects of a chemotherapy session on mitochondrial function of skeletal muscle in breast cancer patients by comparing the first session of TAX to the first session of TAX + TRASTU or +CARBO.', 'timeFrame': 'Change at 4 days post-treatment compare to baseline', 'description': 'difference of a score combining the mitochondrial respiratory capacity with production of hydrogen peroxide, difference in protein levels (western blots) and mRNA (RT-qPCR) expression.'}], 'secondaryOutcomes': [{'measure': 'Compare the effect of the first TAX to the first TAX+TRASTU or +CARBO on muscle fiber cross-sectional area;cellular mechanisms of inflammation,fat infiltration and protein turnover;body composition;strength;muscle architecture and quality of life', 'timeFrame': 'Change at 4 days post-treatment compare to baseline', 'description': 'difference of a score combining the mitochondrial respiratory capacity with production of hydrogen peroxide, difference in protein levels (western blots) and mRNA (RT-qPCR) expression.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Protein turnover', 'Skeletal muscle deconditoning', 'Breast cancer', 'Chemotherapy', 'Muscle biopsy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36094434', 'type': 'BACKGROUND', '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 study aims to investigate the acute effects (i.e. 4 days) of paclitaxel or paclitaxel vs trastuzumab or paclitaxel and carboplatine on skeletal muscle of breast cancer patients. Muscle biopsies will be performed, as well as measurements of body composition strength, muscle architecture and quality of life.', 'detailedDescription': 'Breast cancer patients are commonly treated with chemotherapy, which is known to induce severe side effects such as skeletal muscle deconditioning, characterized by skeletal muscle atrophy and major mitochondrial alterations. These maladaptations, observed in patients treated with epirubicin-cyclophosphamide (EC) followed by weekly paclitaxel (TAX), ultimately lead to reduction in exercise capacity and quality of life. However, little is known about the specific effect of each type of chemotherapy.\n\nIn our recent article (see Citations field in the References module), The investigators demonstrated that chemotherapy effects on skeletal muscle are drug-dependent. Using muscle biopsies before and 4 days after the first administration of EC or TAX, we demonstrated that unlike TAX, EC induced severe muscle atrophy and mitochondrial alterations. Of note, patients in the TAX group had already received EC during the preceding weeks (Figure 1). Therefore, these patients had already begun to have altered skeletal muscle homeostasis, which might have limited the influence of TAX compared with that of its administration in isolation (i.e., without other previous chemotherapy administrations). In addition, some patients had received, concomitantly with TAX, Trastuzumab (TRASTU) due to HER tumor mutation. Also, in triple negative breast cancers, the recommendations concerning neo(adjuvant) chemotherapy have recently changed and recommend starting treatment with the use of paclitaxel + carboplatin (TAX + CARBO).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with early-stage breast cancer receiving chemotherapy. It is planned to include a first group of 10 patients receiving their first administration of TAX and a second group of 10 patients receiving their first administration of TAX+TRASTU. A first session of assessments will take place before the first TAX or TAX+TRASTU session, and a second session 4 days (D4) after the session.\n\nIt is planned to include the same number of patients per group, i.e. 10 patients per group, for a total of 20 patients in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTAX group :\n\n* Female ≥ 18 years\n* Stage I to III breast cancer\n* Patient who has not yet started treatment with TAX\n* Enrolled in a social security scheme\n* Able to speak, read and understand French\n\nTAX+TRASTU group :\n\n* Female ≥ 18 years of age\n* Stage I to III breast cancer\n* Patient who has not yet started treatment with TAX+TRASTU (Tolaney regimen)\n* Enrolled in a social security scheme\n* Able to speak, read and understand French\n\nExclusion Criteria:\n\n* Prior exposure to chemotherapy\n* Musculoskeletal disorders, autoimmune, vascular or neuromuscular disease\n* Implantation of a pacemaker\n* Contraindications to fitness evaluation\n* Contraindication to local anesthesia for microbiopsy\n* Minor or protected adult\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT06536556', 'acronym': 'PROTECT-06-bis', 'briefTitle': 'Effects of a Single Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: Comparison of Paclitaxel vs Paclitaxel + Trastuzumab vs Paclitaxel + Carboplatine: the PROTECT-06 Bis Study', 'organization': {'class': 'OTHER', 'fullName': 'Institut de cancérologie Strasbourg Europe'}, 'officialTitle': 'Effects of a Single Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: Comparison of Paclitaxel vs Paclitaxel + Trastuzumab vs Paclitaxel + Carboplatine: the PROTECT-06 Bis Study', 'orgStudyIdInfo': {'id': '2023-029'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAX Group', 'description': 'Woman with early breast cancer receiving a first cycle of TAX', 'interventionNames': ['Other: First Assessment', 'Other: Second Assessment']}, {'label': 'TAX+TRASTU Group', 'description': 'Woman with early breast cancer receiving a first cycle of TAX+TRASTU', 'interventionNames': ['Other: First Assessment', 'Other: Second Assessment']}, {'label': 'TAX+CARBO Group', 'description': 'oman with early breast cancer receiving a first cycle of TAX+CARBO', 'interventionNames': ['Other: First Assessment', 'Other: Second Assessment']}], 'interventions': [{'name': 'First Assessment', 'type': 'OTHER', 'description': 'pre-treatment assessment', 'armGroupLabels': ['TAX Group', 'TAX+CARBO Group', 'TAX+TRASTU Group']}, {'name': 'Second Assessment', 'type': 'OTHER', 'description': '4 days post-treatment assessment', 'armGroupLabels': ['TAX Group', 'TAX+CARBO Group', 'TAX+TRASTU Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67033', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Institut de cancérologie Strasbourg europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de cancérologie Strasbourg Europe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}