Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk of Fertility Loss Caused by Chemotherapy

Completed

• Conditions: Breast Cancer; Fertility

• Registration Number: NCT02862990
• Lead Sponsor: Latin American Cooperative Oncology Group

Brief Summary

To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.

Detailed Description

To characterize the attitude of pre menopausal patients with breast cancer regarding the risks of infertility based on the following variables:

* Age at diagnosis

* Number of children

* Will of having children

* Marital status

* Scholarity

* Period of time from the diagnosis

* Time of the last menstruation period

* Chemotherapy administration

* Clinical staging at the diagnosis

* Pathological evaluation

* Documentation of the cancer therapy

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-11
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 343

Inclusion Criteria

• Women with age ≥ 18 and ≤ 40
• Indication of (neo) adjuvant chemotherapy
• Prior chemotherapy treatment
• Patients with menstrual periods in the last 6 months
• In use of contraceptive methods
• Without breast cancer recurrence
• Capacity to read and understand the informed consent

Exclusion Criteria

• Patients which received or with indication of definitive ovarian suppression (surgery and/or radiotherapy), except temporary pharmacological ovarian suppression
• Patients whom initiated chemotherapy treatment before entering the study
• Altered state of mind, dementia, or any other psychiatry problem that can interfere in the comprehension or interpretation of the informed consent.
• Previous diagnosis of infertility

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To analyze the number of pre-menopausal patients diagnosed with breast cancer that did not agree in receiving chemotherapy due to the risk of infertility	Baseline and 1 year after after the first interview

Secondary Outcome Measures

Name	Time	Method
Age when diagnosed	Baseline and 1 year after the first interview
Scholarity	Baseline
Period of time since the diagnosis	Baseline
Period of time from the last menstruation period	Baseline and 1 year after the first interview
Description of quality of life of patients with the EORTC QLQ-BR23	Baseline and 1 year after the first interview
Infertility risk for breast cancer patients after accepting chemotherapy	Baseline and 1 year after the first interview
Minimal percentage of cure necessary for patients accept the chemotherapy treatment	Baseline and 1 year after the first interview
Number of children	Baseline and 1 year after the first interview
Desire to have kids	Baseline and 1 year after the first interview
Marital status	Baseline
Chemotherapy scheme administration	Baseline and 1 year after the first interview

Trial Locations

Locations (7)

Hospital Pérola Byington; 🇧🇷 São Paulo, Brazil

CPO - Pucrs; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

HCPA; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Cenro Oncologico Estatal ISSEMYM; 🇲🇽 Toluca de Lerdo, Mexico

INEN; 🇵🇪 Surquillo, Peru

Hospital de Clínicas San Agustín; 🇻🇪 Puerto Cabello, Venezuela

Instituto Nacional de Oncologia y Radiobiologia; 🇨🇺 Havana, Cuba