Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-02-11 @ 11:26 PM
Study NCT ID:
NCT02102568
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2014-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Chemo-induced Menopause on Quality of Life in Women <45 Years Old, Diagnosed With Non-metastatic 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum is collected in order to measure AMH (Anti-Müllerian Hormone) levels, before the start of chemotherapy and after the end of chemotherapy treatment'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-03-31', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the 2-year impact of chemo-induced menopause (CIM) on the functional score of the QLQ-C30 quality of life questionnaire in young women of childbearing age and diagnosed with breast cancer.', 'timeFrame': '3 years', 'description': 'Differential variation of QLQ-C30 QoL Functional Score between inclusion and at 2 years.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the rate of CIM after chemotherapy', 'timeFrame': '3 years', 'description': 'Number of postmenopausal women after chemotherapy'}, {'measure': 'Sensitivity and Specificity of blood Anti-Mullerian Hormone (AMH) in the prediction of MCI', 'timeFrame': '3 years', 'description': 'Blood testing of AMH at baseline and post-chemotherapy'}, {'measure': 'Predictive value of 6-month amenorrhea on 2-year menopause', 'timeFrame': '3 years', 'description': 'Rate of patients recovering after 6 months of amenorrhea'}, {'measure': 'Assessment of FSH (follicle stimulating hormone) and estradiol levels before chemotherapy and at the end of chemotherapy', 'timeFrame': '6 months', 'description': 'Blood levels of FSH and estradiol at baseline and post-treatment'}, {'measure': 'Impact of CIM on specific aspects of quality of life (anxiety, depression, body image, physical activity and quality of sleep) after breast cancer', 'timeFrame': '3 years', 'description': 'Dimensional scores and overall scores of QLQ-BR23 (EORTC), HAD, BIQ (Body Image Questionnaire) questionnaires, Leeds sleep questionnaire, Ricci and Gagnon physical activity questionnaire'}, {'measure': 'Time of onset of amenorrhea in terms of type of chemotherapy', 'timeFrame': '6 months to 1 year', 'description': 'Time of onset of amenorrhea according to the type of chemotherapy (Kaplan-Meier method)'}, {'measure': 'Time of onset of amenorrhea in terms of patient age', 'timeFrame': '6 months to 1 year', 'description': 'Occurrence of MCI according to age'}, {'measure': 'Differential variation of the symptomatic score of the QLQ-C30 questionnaire at 2 years according to menopausal status', 'timeFrame': '3 years', 'description': 'QLQ-C30 Quality of Life Questionnaire Score'}, {'measure': 'Longitudinal study of the quality of life of patients after treatment according to whether patients are menopausal or not', 'timeFrame': '3 years', 'description': '90/5000 Overall score of quality of life of patients at inclusion, at 1, 2 and 3 years post-inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'Chemotherapy-induced menopause', 'quality of life'], 'conditions': ['BREAST CANCER']}, 'descriptionModule': {'briefSummary': 'Prospective multicenter study, Not on Health Products that evaluates up to 2 and a half years the impact of chemo-induced menopause (CIM) on the functional score of the QLQ-C30 quality of life questionnaire in young women of childbearing age, diagnosed with non-metastatic breast cancer.', 'detailedDescription': 'Approximately 20% of women with breast cancer are still of childbearing age and are likely to benefit from chemotherapy. Since Chemotherapy-Induced Menopause (CIM) may be one of its consequences, it seems important to study its impact on the quality of life of these young patients. It is within this framework that the Jean Perrin Center promoted the MENOCOR study, whose main objective is to assess the impact of the CIM on the quality of life through the QLQ-C30 functional score over a two-year period. The CIM incidence, its impact on quality of life (body image, anxiety, depression, physical activity and sleep quality) and the onset of climacteric signs, the onset of amenorrhea according to chemotherapy protocols and patient age and hormonal variations are among the secondary objectives of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'premenopausal women with age between 18 to 45 years. premenopausal women with non-metastatic breast cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged over 18 and under 45\n* Patient without amenorrhea at diagnosis\n* Performance status less than 2 (according to WHO criteria )\n* Patient diagnosed with histologically proven non-metastatic breast cancer\n* Clinical Stages I, IIA, IIB and IIIA\n* Positive Hormone Receptors (defined by a rate of 10% of labeled cells and immunohistochemistry (IHC) ) or negative\n* Positive or negative HER2 status ( defined a score of 0 or 1 + by IHC , or a 2 + score by IHC and FISH / ISHS / CISH negative)\n* Patients to be treated with neoadjuvant or adjuvant chemotherapy\n* Satisfying hematological, renal and hepatic functions : PNN\\> 2,109 / L, platelets \\> 100 . 109 / L, Hb\\> 10 g / dl , normal bilirubin, AST and ALT \\<2.5 upper normal value ( VNS) , alkaline phosphatase \\<2.5 VSN , creatinine clearance \\> 60 ml / min\n* Obtaining informed consent in writing, signed and dated\n* Affiliation to Social Security system (or being the beneficiary of such a plan) under the terms of the Act of August 9, 2004\n\nExclusion Criteria:\n\n* Male patient\n* Metastatic cancer\n* Any T4 tumor (skin invasion, deep grip, inflammatory breast cancer)\n* Patient who underwent surgical castration of ovariectomy or hysterectomy or tubal ligation\n* Patients with endometriosis\n* Pregnant or breastfeeding patients\n* Patients with no effective contraception\n* Patients who have had hormone therapy or chemotherapy\n* Patient who have already taken Gn-RH or LH-RH analogues (chemical castration)\n* Patient whose mother was in menopause early without treatment\n* Presence of comorbidities related to fertility or medical history related to ovarian failure or sterility\n* Significant neurological or psychiatric abnormalities\n* Inability of the patient to complete the questionnaires (the language barrier)\n* Patients deprived of liberty by court or administrative decision\n* Patient with another pathology deemed incompatible with the inclusion of the patient in the protocol\n* Participation in another clinical trial involving the chemical or surgical castration of the patient\n* Patients geographically unstable in the 6 months following inclusion or residing away from the treatment center and thereby making it difficult to monitor'}, 'identificationModule': {'nctId': 'NCT02102568', 'acronym': 'MENOCOR', 'briefTitle': 'Impact of Chemo-induced Menopause on Quality of Life in Women <45 Years Old, Diagnosed With Non-metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Jean Perrin'}, 'officialTitle': 'Study of the Impact of Chemo-induced Menopause on the Quality of Life in Young Women of Childbearing Age and Diagnosed With Non-metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '2013-A01284-41'}}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre de lutte contre le cancer - Centre Jean PERRIN', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Reims', 'country': 'France', 'facility': 'Institut Jean Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Marie-Ange MOURET-REYNIER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Jean Perrin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Jean Perrin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}