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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Differential variation of QLQ-C30 QoL Functional Score between inclusion and at 2 years. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the rate of CIM after chemotherapy | Number of postmenopausal women after chemotherapy | 3 years |
| Sensitivity and Specificity of blood Anti-Mullerian Hormone (AMH) in the prediction of MCI |
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Inclusion Criteria:
Exclusion Criteria:
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premenopausal women with age between 18 to 45 years. premenopausal women with non-metastatic breast cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Ange MOURET-REYNIER, Dr | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de lutte contre le cancer - Centre Jean PERRIN | Clermont-Ferrand | 63000 | France | |||
| Institut Jean Godinot |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Serum is collected in order to measure AMH (Anti-Müllerian Hormone) levels, before the start of chemotherapy and after the end of chemotherapy treatment
Blood testing of AMH at baseline and post-chemotherapy
| 3 years |
| Predictive value of 6-month amenorrhea on 2-year menopause | Rate of patients recovering after 6 months of amenorrhea | 3 years |
| Assessment of FSH (follicle stimulating hormone) and estradiol levels before chemotherapy and at the end of chemotherapy | Blood levels of FSH and estradiol at baseline and post-treatment | 6 months |
| Impact of CIM on specific aspects of quality of life (anxiety, depression, body image, physical activity and quality of sleep) after breast cancer | Dimensional scores and overall scores of QLQ-BR23 (EORTC), HAD, BIQ (Body Image Questionnaire) questionnaires, Leeds sleep questionnaire, Ricci and Gagnon physical activity questionnaire | 3 years |
| Time of onset of amenorrhea in terms of type of chemotherapy | Time of onset of amenorrhea according to the type of chemotherapy (Kaplan-Meier method) | 6 months to 1 year |
| Time of onset of amenorrhea in terms of patient age | Occurrence of MCI according to age | 6 months to 1 year |
| Differential variation of the symptomatic score of the QLQ-C30 questionnaire at 2 years according to menopausal status | QLQ-C30 Quality of Life Questionnaire Score | 3 years |
| Longitudinal study of the quality of life of patients after treatment according to whether patients are menopausal or not | 90/5000 Overall score of quality of life of patients at inclusion, at 1, 2 and 3 years post-inclusion | 3 years |
| Reims |
| France |
| CHU Saint Etienne | Saint-Etienne | France |
| D017437 |
| Skin and Connective Tissue Diseases |