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

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• France
  • Clermont Ferrand, France, 63000
    • Centre de lutte contre le cancer - Centre Jean PERRIN
  • Reims, France
    • Institut Jean Godinot
  • Saint Etienne, France
    • CHU Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

premenopausal women with age between 18 to 45 years. premenopausal women with non-metastatic breast cancer.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Principal Investigator: Marie-Ange MOURET-REYNIER, Dr, Centre Jean Perrin

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimated): April 3, 2014

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; quality of life; Chemotherapy-induced menopause
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2013-A01284-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No