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

February 13, 2024 updated by: Centre Jean Perrin

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 3 years
Differential variation of QLQ-C30 QoL Functional Score between inclusion and at 2 years.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the rate of CIM after chemotherapy
Time Frame: 3 years
Number of postmenopausal women after chemotherapy
3 years
Sensitivity and Specificity of blood Anti-Mullerian Hormone (AMH) in the prediction of MCI
Time Frame: 3 years
Blood testing of AMH at baseline and post-chemotherapy
3 years
Predictive value of 6-month amenorrhea on 2-year menopause
Time Frame: 3 years
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
Time Frame: 6 months
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
Time Frame: 3 years
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 Frame: 6 months to 1 year
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
Time Frame: 6 months to 1 year
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
Time Frame: 3 years
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
Time Frame: 3 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Jean Perrin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Ange MOURET-REYNIER, Dr, Centre Jean Perrin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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