ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02862990
Date of registration:	27/01/2016
Prospective Registration:	No
Primary sponsor:	Latin American Cooperative Oncology Group
Public title:	Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk of Fertility Loss Caused by Chemotherapy
Scientific title:	Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk
Date of first enrolment:	May 2015
Target sample size:	343
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02862990
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Brazil	Cuba	Mexico	Peru	Venezuela

Contacts

Name:	Gustavo Werutsky, MD
Address:
Telephone:
Email:
Affiliation:	Latin American Cooperative Oncology Group

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Fertility

Intervention(s)

Primary Outcome(s)

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 [Time Frame: Baseline and 1 year after after the first interview]

Secondary Outcome(s)

Period of time from the last menstruation period [Time Frame: Baseline and 1 year after the first interview]

Period of time since the diagnosis [Time Frame: Baseline]

Number of children [Time Frame: Baseline and 1 year after the first interview]

Description of quality of life of patients with the EORTC QLQ-BR23 [Time Frame: Baseline and 1 year after the first interview]

Infertility risk for breast cancer patients after accepting chemotherapy [Time Frame: Baseline and 1 year after the first interview]

Desire to have kids [Time Frame: Baseline and 1 year after the first interview]

Chemotherapy scheme administration [Time Frame: Baseline and 1 year after the first interview]

Marital status [Time Frame: Baseline]

Age when diagnosed [Time Frame: Baseline and 1 year after the first interview]

Minimal percentage of cure necessary for patients accept the chemotherapy treatment [Time Frame: Baseline and 1 year after the first interview]

Scholarity [Time Frame: Baseline]

Secondary ID(s)

LACOG 0414

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Grupo de Estudios Clínicos Oncológicos Peruano

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.