NCT02102568Completed
Impact of Chemo-induced Menopause on Quality of Life in Women <45 Years Old, Diagnosed With Non-metastatic Breast Cancer
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
Source: ClinicalTrials.gov · Last updated 14 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 240 (actual)
- First submitted
- 20 Mar 2014
- Start date
- Apr 2014
- Primary completion date
- 10 Jul 2020
- Lead sponsor
- Centre Jean Perrin
- Diseases
- Metastatic breast cancer
- NCT number
- NCT02102568
What you commit to
- Study type: Observational
- Participants enrolled: 240
- From Apr 2014 to the primary completion date, 10 Jul 2020
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who underwent surgical castration of ovariectomy or hysterectomy or tubal ligation
- Patients who have had hormone therapy or chemotherapy
- Participation in another clinical trial involving the chemical or surgical castration of the patient
Other illness
- Metastatic cancer
- Any T4 tumor (skin invasion, deep grip, inflammatory breast cancer)
- Presence of comorbidities related to fertility or medical history related to ovarian failure or sterility
- Significant neurological or psychiatric abnormalities
Other
- Male patient
- Patients with endometriosis
- Pregnant or breastfeeding patients
- Patients with no effective contraception
- Patient who have already taken Gn-RH or LH-RH analogues (chemical castration)
- Patient whose mother was in menopause early without treatment
- 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
- Patients geographically unstable in the 6 months following inclusion or residing away from the treatment center and thereby making it difficult to monitor
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de lutte contre le cancer - Centre Jean PERRIN Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Institut Jean Godinot Coordinator of this site? Confirm its status | Reims | France | Unknown status |
| CHU Saint-Etienne Coordinator of this site? Confirm its status | Saint-Etienne | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.