Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-27 @ 9:17 AM
Study NCT ID:
NCT02433067
Status:
TERMINATED
Last Update Posted:
2020-10-06
First Post:
2015-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Intervention on Myocardial Function in Patients With HER2 + 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': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2015-04-14', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change', 'description': 'evaluated with echocardiography'}], 'secondaryOutcomes': [{'measure': 'Weight and volume of left and right ventricular', 'timeFrame': 'baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with echocardiography'}, {'measure': 'Body composition', 'timeFrame': 'baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated byimpedance and with tape measure and pliers of Harpenden'}, {'measure': 'Metabolic responses', 'timeFrame': 'baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with enzyme-linked immunosorbent assay (ELISA)'}, {'measure': 'Maximal voluntary quadriceps', 'timeFrame': 'baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with chair quadriceps with strain gauge'}, {'measure': 'score of Quality of life', 'timeFrame': 'Baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with questionnaire'}, {'measure': 'score of Pain', 'timeFrame': 'Baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with questionnaire'}, {'measure': 'Fatigue', 'timeFrame': 'baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with questionnaire'}, {'measure': 'Level of physical activity', 'timeFrame': 'baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with questionnaire'}, {'measure': 'Pulmonary function (at rest and during exercise)', 'timeFrame': 'baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with respiratory functional test and maximal exercise test'}, {'measure': 'hormonal responses', 'timeFrame': 'baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with enzyme-linked immunosorbent assay (ELISA)'}, {'measure': 'inflammatory responses', 'timeFrame': 'baseline (T0), 3 months (T3) and 6 months (T6)', 'description': 'evaluated with enzyme-linked immunosorbent assay (ELISA)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36211552', 'type': 'DERIVED', 'citation': 'Jacquinot Q, Meneveau N, Falcoz A, Bouhaddi M, Roux P, Degano B, Chatot M, Curtit E, Mansi L, Paillard MJ, Bazan F, Chaigneau L, Dobi E, Meynard G, Vernerey D, Pivot X, Mougin F. Cardiotoxicity is mitigated after a supervised exercise program in HER2-positive breast cancer undergoing adjuvant trastuzumab. Front Cardiovasc Med. 2022 Sep 23;9:1000846. doi: 10.3389/fcvm.2022.1000846. eCollection 2022.'}, {'pmid': '28629338', 'type': 'DERIVED', 'citation': 'Jacquinot Q, Meneveau N, Chatot M, Bonnetain F, Degano B, Bouhaddi M, Dumoulin G, Vernerey D, Pivot X, Mougin F. A phase 2 randomized trial to evaluate the impact of a supervised exercise program on cardiotoxicity at 3 months in patients with HER2 overexpressing breast cancer undergoing adjuvant treatment by trastuzumab: design of the CARDAPAC study. BMC Cancer. 2017 Jun 19;17(1):425. doi: 10.1186/s12885-017-3420-4.'}]}, 'descriptionModule': {'briefSummary': 'Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer', 'detailedDescription': 'Primary objective: To evaluate in patients with HER2 + breast cancer, treated only by trastuzumab, the impact of three months individualized physical activity intervention (55 minutes, 3 times per week) on left ventricular ejection fraction (LVEF).\n\nSecondary objectives: To evaluate the impact of physical activity intervention on body composition, muscle function, metabolic, hormonal and inflammatory responses, pain, fatigue and quality of life.\n\nThis study examines patients aged 18 to 85 years, diagnosed with early breast cancer with HER2 overexpression confirmed histologically and eligible to receive treatment with trastuzumab (adjuvant).\n\nThis study includes 3 assessments phases: baseline (T0), 3 months (T3) and 6 months (T6) for both arms.\n\nThe programme is organised as follows: Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " for 3 months ; Arm B (control group) "standard oncologic care".\n\nBetween T3 and T6, volontary physical activity level will follow by actimetry.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 85 years\n* First breast cancer HER2 + histologically confirmed,\n* WHO grade Performance Index ≤1\n* Normal renal function (creatinine clearance ≥ 60 ml min-1)\n* Normal heart function with LVEF ≥ 50%\n* Normal liver function (AST and ALT normal)\n* Physical activity certificate issued by a cardiologist or an oncologist,\n* Active contraception or postmenopausal\n\nExclusion Criteria:\n\n* Patients aged under 18 and over 85\n* Patients having no breast cancer HER2+\n* Patients with metastases\n* Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%),\n* Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)\n* Symptomatic osteoarthritis,\n* Cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease)\n* Patients suffering from malnutrition (Body Mass Index (BMI) \\<18 kg m-2) or weight loss of over 10% during the last 3 months,\n* Patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity\n* Pregnant or lactating Patients.'}, 'identificationModule': {'nctId': 'NCT02433067', 'acronym': 'CARDAPAC', 'briefTitle': 'Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Franche-Comté'}, 'officialTitle': 'Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant', 'orgStudyIdInfo': {'id': 'UFranche-Comte'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity intervention', 'description': '\\- Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months', 'interventionNames': ['Other: Physical activity intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '\\- Arm B (control group) "standard oncologic care"', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Physical activity intervention', 'type': 'OTHER', 'description': 'Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week.', 'armGroupLabels': ['Physical activity intervention']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'standard oncologic care', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'state': 'Doubs', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Nathalie Meneveau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Besançon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Franche-Comté', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ligue contre le cancer, France', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Fabienne Mougin-Guillaume', 'investigatorAffiliation': 'University of Franche-Comté'}}}}