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

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05409222
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Anticipated Duration (Months): 42.6
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hereditary Breast and Ovarian Cancer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Study of Quality of Life Post Preventive Salpingo-oophorectomy in Healthy BRCA1/2 and PALB2 Mutation Carriers
• Actual Study Start Date: Mar 12, 2020
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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 blood pressure (mmHg)

3. 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 lipids levels (cholesterol, triglycerides, HDL, LDL and VLDL)

4. 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

5. 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)

6. 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

7. 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.

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• ClinicalTrials.gov Identifier: NCT05409222
• Other Study ID Numbers: IIBSP-ECV-2019-103
• First Posted: Jun 8, 2022
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Additional relevant MeSH terms: Hereditary Breast and Ovarian Cancer Syndrome

Study Results

No Results Posted as of Jun 8, 2022