Clinical trial · Observational
Impact of Chemo-induced Menopause on Quality of Life in Women <45 Years Old, Diagnosed With Non-metastatic Breast Cancer
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
NCT02102568CI-TRIAL-00073994MENOCORcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BREAST CANCER | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
Secondary outcomes (9)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Patient aged over 18 and under 45 * Patient without amenorrhea at diagnosis * Performance status less than 2 (according to WHO criteria ) * Patient diagnosed with histologically proven non-metastatic breast cancer * Clinical Stages I, IIA, IIB and IIIA * Positive Hormone Receptors (defined by a rate of 10% of labeled cells and immunohistochemistry (IHC) ) or negative * 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) * Patients to be treated with neoadjuvant or adjuvant chemotherapy * 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 * Obtaining informed consent in writing, signed and dated * Affiliation to Social Security system (or being the beneficiary of such a plan) under the terms of the Act of August 9, 2004 Exclusion Criteria: * Male patient * Metastatic cancer * Any T4 tumor (skin invasion, deep grip, inflammatory breast cancer) * Patient who underwent surgical castration of ovariectomy or hysterectomy or tubal ligation * Patients with endometriosis * Pregnant or breastfeeding patients * Patients with no effective contraception * Patients who have had hormone therapy or chemotherapy * Patient who have already taken Gn-RH or LH-RH analogues (chemical castration) * Patient whose mother was in menopause early without treatment * Presence of comorbidities related to fertility or medical history related to ovarian failure or sterility * Significant neurological or psychiatric abnormalities * Inability of the patient to complete the questionnaires (the language barrier) * Patients deprived of liberty by court or administrative decision * Patient with another pathology deemed incompatible with the inclusion of the patient in the protocol * Participation in another clinical trial involving the chemical or surgical castration of the patient * Patients geographically unstable in the 6 months following inclusion or residing away from the treatment center and thereby making it difficult to monitor
References
Publications (0)
Data not yet available
No reference posted for this study.