AzTrials
AzTrials

BREAST CANCERMENOCORNCT02102568

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

An observational study of BREAST CANCER, run by Centre Jean Perrin at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
BREAST CANCER
How many people
240 participants
Where
3 sitesFrance
Study dates
Apr 2014to 11 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Centre de lutte contre le cancer - Centre Jean PERRIN

    Clermont-Ferrand, 63000

  • Institut Jean Godinot

    Reims

  • CHU Saint Etienne

    Saint-Etienne

Other trials in France

About this study

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

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.

Read the 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
Keywords
breast cancer, Chemotherapy-induced menopause, quality of life
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

Secondary outcomes (9)

  1. Evaluation of the rate of CIM after chemotherapy

    Number of postmenopausal women after chemotherapy

    Measured: 3 years

  2. Sensitivity and Specificity of blood Anti-Mullerian Hormone (AMH) in the prediction of MCI

    Blood testing of AMH at baseline and post-chemotherapy

    Measured: 3 years

  3. Predictive value of 6-month amenorrhea on 2-year menopause

    Rate of patients recovering after 6 months of amenorrhea

    Measured: 3 years

  4. 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

    Measured: 6 months

  5. 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

    Measured: 3 years

  6. 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)

    Measured: 6 months to 1 year

  7. Time of onset of amenorrhea in terms of patient age

    Occurrence of MCI according to age

    Measured: 6 months to 1 year

  8. 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

    Measured: 3 years

  9. 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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completion10 Jul 2020
  4. Study completion11 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02102568
Sponsor's protocol ID
2013-A01284-41
Acronym
MENOCOR
Status last verified
Aug 2021
First submitted
20 Mar 2014
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of BREAST CANCER, run by Centre Jean Perrin at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02102568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in