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Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger

NCT03470935 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-01-16

No results posted yet for this study

Summary

Brest cancer is the most common cancer in women in France with 52.000 new cases diagnosed in 2010 including nearly 6.000 women younger than 40.

The improvement of the fertility conservation of cancer patients is one of the goals put forward by the french Cancer Plan (Objective 8.1).

The issue of fertility after a breast cancer is a frequently raised subjects by the concerned couples today. The improvement in prognosis due to therapeutic advances combined with the increasing age of the first pregnancy and in the recomposed couples bring number of young women between 35 and 40 years followed for breast cancer today to raise these questions with their oncologists.

Young women have a greater risk to develop agressive tumors requiring a mulitimodal treatment whose general and gonadic side effects can be important and permanently impact the reproductive capacity. At the time of diagnosis, almost 50% of these young patients report that they want to consider a later pregnancy but no data are available on the evolution of this wish over time although it is known that anti-cancer treatments have a serious impact on future possibilities of pregnancy(s).

The sequential chemotherapy regimen prescribed in adjuvant or neo-adjuvant situation includes intercaling agents (antracyclines) and an alkylating agent (cyclophosphamide) partially responsible for subsequent fertility disorders. In addition, a chemotherapy-induced amenorrhea (CAI) occurs in 50 to 80% of women according to the studies, the latter is sometines definitive and sequellar of treatment. However, few data describe the time of recovery of menstrual cycles in women with CAI and subsequent impact of fertility.

The aim of this study is to evaluate the impact of cancer diagnosis and treatment on the wishes of fertility before and after the management of cancer of the patients in question, on the recovery of menstrual cycles and the quality of sexual life of these patients.

The investigators hope to improve the pre-therapeutic evaluation of women wishing to implement measures to preserve fertility, to assist women wishing to consider this type of project after cytotoxic treatments and accompany women suffering from a change in self-image that has an impact on their quality of life. These results could help to sensitize the doctors to the difficulties encountered by young women and to improve and/or to strengthen the global and adapted care of these patients.

Conditions

  • Breast Cancer Female

Sponsors & Collaborators

  • Hôpital Privé des Côtes d'Armor (HPCA)

    lead OTHER

Principal Investigators

  • Jérôme Martin-Babau · Hôpital Privé des Côtes d'Armor (HPCA)

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03470935 on ClinicalTrials.gov