Impact of Chemo-induced Menopause on Quality of Life in Women <45 Years Old, Diagnosed With Non-metastatic Breast Cancer

NCT ID: NCT02102568

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2023-12-11

Brief Summary

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.

Detailed Description

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.

Conditions

BREAST CANCER

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Jean Perrin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Ange MOURET-REYNIER, Dr

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin

Locations

Centre de lutte contre le cancer - Centre Jean PERRIN

Clermont-Ferrand, , France

Institut Jean Godinot

Reims, , France

CHU Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2013-A01284-41

Identifier Type: -

Identifier Source: org_study_id