Clinical trial NCT02102568: Impact of Chemo-induced Menopause on Quality of Life in Women <45 Years Old, Diagnosed With Non-metastatic Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BREAST CANCER
Keywords: breast cancer
Chemotherapy-induced menopause
quality of life
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: premenopausal women with age between 18 to 45 years. premenopausal women with non-metastatic breast cancer.

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.

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

Primary outcomes:
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.
timeFrame: 3 years
Secondary outcomes:
measure: Evaluation of the rate of CIM after chemotherapy
timeFrame: 3 years
measure: Sensitivity and Specificity of blood Anti-Mullerian Hormone (AMH) in the prediction of MCI
timeFrame: 3 years
measure: Predictive value of 6-month amenorrhea on 2-year menopause
timeFrame: 3 years
measure: Assessment of FSH (follicle stimulating hormone) and estradiol levels before chemotherapy and at the end of chemotherapy
timeFrame: 6 months
measure: Impact of CIM on specific aspects of quality of life (anxiety, depression, body image, physical activity and quality of sleep) after breast cancer
timeFrame: 3 years
measure: Time of onset of amenorrhea in terms of type of chemotherapy
timeFrame: 6 months to 1 year
measure: Time of onset of amenorrhea in terms of patient age
timeFrame: 6 months to 1 year
measure: Differential variation of the symptomatic score of the QLQ-C30 questionnaire at 2 years according to menopausal status
timeFrame: 3 years
measure: Longitudinal study of the quality of life of patients after treatment according to whether patients are menopausal or not
timeFrame: 3 years
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Centre de lutte contre le cancer - Centre Jean PERRIN
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Etienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: Centre Jean Perrin
name: Marie-Ange MOURET-REYNIER, Dr
role: PRINCIPAL_INVESTIGATOR
References: