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

BREAST CANCER Clinical Trial

— MENOCOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102568
• Other study ID #: 2013-A01284-41
• Status: Completed
• Start date: April 2014
• Est. completion date: December 11, 2023

Study information

• Verified date: August 2021
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 11, 2023
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• BREAST CANCER
• Breast Neoplasms

Locations

Country	Name	City	State
France	Centre de lutte contre le cancer - Centre Jean PERRIN	Clermont Ferrand
France	Institut Jean Godinot	Reims
France	CHU Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of the rate of CIM after chemotherapy	Number of postmenopausal women after chemotherapy	3 years
Secondary	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
Secondary	Predictive value of 6-month amenorrhea on 2-year menopause	Rate of patients recovering after 6 months of amenorrhea	3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Time of onset of amenorrhea in terms of patient age	Occurrence of MCI according to age	6 months to 1 year
Secondary	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
Secondary	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