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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hereditary Breast and Ovarian Cancer

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Teresa Ramon y Cajal, MD PhD; Phone Number: 5634 + 34 93 556 56 38; Email: tramon@santpau.cat
• Study Contact Backup: Name: Nuria Calvo, MD; Phone Number: + 34 93 556 56 38; Email: ncalvo@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital De La Santa Creu I Sant Pau
    • Contact: Teresa Ramon y Cajal, MD PhD; Phone Number: 5634 +34935565638; Email: tramon@santpau.cat
    • Contact: Nuria Calvo, MD; Phone Number: +34935565638; Email: ncalvo@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women identified and followed at the Hospital de la Santa Creu i Sant Pau.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cohort 1A: preventive salpingo-oophorectomy with hormone replacement therapy; Healthy carriers who decide undergo preventive surgery and opt to have hormone replacement therapy
Cohort 1B: preventive salpingo-oophorectomy without hormone replacement therapy; Healthy carriers who decide undergo preventive surgery and reject hormone replacement therapy
Cohort 2: without preventive salpingo-oophorectomy; Healthy carriers who decide not to proceed to preventive surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Teresa Ramon y Cajal, MD PhD, Hospital Santa Cruz y San Pablo

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 12, 2020
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: March 13, 2021
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (ACTUAL): June 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Breast Diseases; Genetic Diseases, Inborn; Neoplastic Syndromes, Hereditary; Ovarian Neoplasms; Breast Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome
• Other Study ID Numbers: IIBSP-ECV-2019-103