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

Hereditary Breast and Ovarian Cancer Clinical Trial

— BRCA-HRT  

Official title:

Study of Quality of Life Post Preventive Salpingo-oophorectomy in Healthy BRCA1/2 and PALB2 Mutation Carriers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05409222
• Other study ID #: IIBSP-ECV-2019-103
• Status: Recruiting
• Start date: March 12, 2020
• Est. completion date: October 2023

Study information

• Verified date: June 2022
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Teresa Ramon y Cajal, MD PhD
• Phone: + 34 93 556 56 38
• Email: tramon[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the scale MenCav of quality of life in premenopausal carriers opting and rejecting hormone replacement therapy post salpingo-oophorectomy	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.	5 years
Secondary	To compare the impact of hormone replacement therapy on number and description of cardiovascular events	To describe cardiovascular risk we used changes in the weight of patients. Weight in kilograms, height in meters and weight and height will be combined to report BMI in kg/m^2.	5 years
Secondary	To compare the impact of hormone replacement therapy on number and description of cardiovascular events	To describe cardiovascular risk we used changes in blood pressure (mmHg)	5 years
Secondary	To compare the impact of hormone replacement therapy on number and description of cardiovascular events	To describe cardiovascular risk we used changes in lipids levels (cholesterol, triglycerides, HDL, LDL and VLDL)	5 years
Secondary	To compare the impact of hormone replacement therapy on number and description of cardiovascular events	To describe cardiovascular risk we used eventual cardiovascular adverse events	5 years
Secondary	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	By performing bone densitometry we will be able to quantify the number of participants with adverse events related to bone loss (osteoporosis or osteopenia)	5 years
Secondary	Comparison of overall cancer survival between women deciding risk-reducing surgery and those rejecting it.	We will analyze and compare the mean of overall survival of women undergoing for risk-reducing surgery and those rejecting it	5 years
Secondary	Comparison of mean of breast cancer specific survival between women deciding gynecological surgery and those rejecting surgery.	We will analyze and compare the mean of breast cancer specific survival in women undergoing surgery and those rejecting it.	5 years
Secondary	Comparison of gynecologic cancer survival between women deciding preventive surgery and those rejecting it.	We will analyze and compare the mean of gynecologic cancer survival of women undergoing surgery and those rejecting it.	5 years