Study of Quality of Life Post Salpingo-oophorectomy in BRCA1/2 & PALB2 Mutation Carriers (BRCA-HRT)

• Conditions: Hereditary Breast and Ovarian Cancer

• Registration Number: NCT05409222
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

1. Premenopausal BRCA1 / 2 or PALB2 gene mutation carriers who receive hormone replacement therapy (HRT) after preventive salpingo-oophorectomy (PBSO) have a better quality of sexual, psychological, cardiovascular and bone health than carriers who decline HRT.

2. Premenopausal mutation carriers treated with PBSO who choose HRT have a comparable overall survival and specific survival for breast / gynecological cancer to women who undergo surgery and refuse to receive HRT.

3. Premenopausal mutation carriers treated with PBSO have better overall and specific breast / gynecological cancer survival than non-SOBP carriers.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-12
• Study First Submitted: 2021-03-13
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-03
• Last Update Submitted: 2022-06-03
• Study First Posted: 2022-06-08
• Last Update Posted: 2022-06-08
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

1. Age between 30 and 49 years
2. Being a member of a family with a history of hereditary breast and ovarian cancer, with a cancer risk> 10% or being a carrier of the BRCA1 / 2 or PALB2 mutation.

Exclusion Criteria

1. Personal history of oophorectomy for benign or malignant ovarian pathology.
2. Personal history of breast cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the scale MenCav of quality of life in premenopausal carriers opting and rejecting hormone replacement therapy post salpingo-oophorectomy	5 years	Questionnaire to measure quality of life in post-menopausal women (the Mencav questionnaire). This questionnaire consists of questions with 5 possible answers, answer 1 is the worst result and question 5 is the best result, so low scores mean worse results and high scores better results.

Secondary Outcome Measures

Name	Time	Method
Comparison of mean of breast cancer specific survival between women deciding gynecological surgery and those rejecting surgery.	5 years	We will analyze and compare the mean of breast cancer specific survival in women undergoing surgery and those rejecting it.
To compare the impact of hormone replacement therapy on number and description of cardiovascular events	5 years	To describe cardiovascular risk we used eventual cardiovascular adverse events
To compare the impact of hormone replacement therapy on number and description of bone loss related events in premenopausal carriers after salpingo-oophorectomy we will perform bone densitometry	5 years	By performing bone densitometry we will be able to quantify the number of participants with adverse events related to bone loss (osteoporosis or osteopenia)
Comparison of gynecologic cancer survival between women deciding preventive surgery and those rejecting it.	5 years	We will analyze and compare the mean of gynecologic cancer survival of women undergoing surgery and those rejecting it.
Comparison of overall cancer survival between women deciding risk-reducing surgery and those rejecting it.	5 years	We will analyze and compare the mean of overall survival of women undergoing for risk-reducing surgery and those rejecting it

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain