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Study the Impact of Chemo-induced Menopause on the Quality of Life in Young Women of Childbearing Age and Diagnosed With Non-metastatic Breast Cancer (menocor)

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ClinicalTrials.gov Identifier: NCT02102568
Recruitment Status : Recruiting
First Posted : April 3, 2014
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin

Brief Summary:
Prospective multicenter study, Out Health Products that evaluates to 2 years the impact of chemo-induced menopause (MCI) on the functional score of quality of life questionnaire QLQ-C30 in young women age childbearing and living with breast cancer.

Condition or disease
BREAST CANCER

Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
diagnostic
quality of life score and dosage



Primary Outcome Measures :
  1. Evaluation of the 2-year impact of chemo-induced menopause (MCI) on the functional score of quality of life questionnaire QLQ-C30 in young women of childbearing age and diagnosed with breast cancer. [ Time Frame: until 12 months ]

Secondary Outcome Measures :
  1. Evaluation of the rate of MCI after chemotherapy [ Time Frame: until 6 months ]
  2. Sensitivity and Specificity of Anti-Mullerian Hormone blood AMH in the prediction of MCI [ Time Frame: until 6 months ]
  3. Predictive value of amenorrhea 6 months to 2 years of menopause [ Time Frame: until 6 months ]
  4. Assessment of change in FSH (Follicle Stimulating Hormone) and estradiol before chemotherapy and at the end of chemotherapy [ Time Frame: until 24 months ]
  5. Impact of MCI on specific aspects of quality of life (anxiety, depression, body image, sporting activity and quality of sleep) after breast cancer [ Time Frame: until 24 months ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
premenopausal women with age between 18 to 45 years. premenopausal women with breast cancer non metastatic.
Criteria

Inclusion Criteria:

  • Patient aged over 18 and under 45
  • Patient without amenorrhea at diagnosis
  • Performance status 2 (according to WHO criteria )
  • Patient diagnosed with histologically proven breast cancer , non metastatic Clinical Stages I , IIA , IIB and IIIA
  • Positive Hormone Receptors (defined by a rate of 10% of labeled cells and immunohistochemistry (IHC) ) or negative
  • Status HER2 positive or HER2 negative ( defined a score of 0 or 1 + by IHC , or a 2 + score by IHC and FISH / ISHS / CISH negative)
  • Patients treated with neoadjuvant or adjuvant chemotherapy hematological, renal and hepatic functions satisfying : ANC> 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 Social Security system (or be the beneficiary of such a plan ) under the terms of the Act of August 9, 2004

Exclusion Criteria:

  • Patient male
  • Cancer metastatic
  • Any tumor T4 ( skin invasion , deep grip, inflammatory breast cancer )
  • Patient who underwent surgical castration of ovariectomy type hysterectomy or tubal ligation
  • Please have endometriosis
  • Please pregnant or nursing
  • Please not using effective contraception
  • Patient who have had hormone therapy or chemotherapy
  • Patient who have already taken similar Gn -RH or LH -RH (chemical castration)
  • Patient whose mother was early menopause without treatment
  • Presence of comorbidities related to fertility or medical history related to fertility ovarian failure types or sterility
  • significant neurological or psychiatric abnormalities
  • Inability of the patient to complete the questionnaires ( the language barrier )
  • Private Patient freedom by court or administrative
  • Patient with another pathology deemed incompatible with the input of the patient in the protocol
  • Participation in another clinical trial involving the chemical or surgical castration of the patient
  • Please geographically unstable in the next 6 months or residing away from the treatment center and thereby making it difficult to monitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102568


Contacts
Contact: Judith PASSILDAS 0033463663337 judith.passildas@clermont.unicancer.fr

Locations
France
Centre Jean PERRIN Recruiting
Clermont-ferrand, France, 63000
Contact: Judith PASSILDAS    0033463663337      
Principal Investigator: Marie-Ange MOURET-REYNIER         
Centre Emile Roux Active, not recruiting
Le puy-en Velay, France
Institut Jean Godinot Recruiting
Reims, France
Contact: Judith PASSILDAS    0033463663337      
Institut Lucien Neuwirth Recruiting
Saint Etienne, France
Contact: Judith PASSILDAS    0033463663337      
Sponsors and Collaborators
Centre Jean Perrin

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT02102568     History of Changes
Other Study ID Numbers: 2013-A01284-41
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases