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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05409222

Acronym

BRCA-HRT

Enrollment

Registered

2022-06-08

Start date

2020-03-12

Completion date

2023-10-31

Last updated

2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Breast and Ovarian Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 49 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
To compare the impact of hormone replacement therapy on number and description of cardiovascular events	5 years	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.
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 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
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.
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.

Countries

Spain

Contacts

Primary ContactTeresa Ramon y Cajal, MD PhD

tramon@santpau.cat+ 34 93 556 56 38

Backup ContactNuria Calvo, MD

ncalvo@santpau.cat+ 34 93 556 56 38

Outcome results