Health After eaRly Menopause Due to Oophorectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bone Mineral Density
- BRCA1 Mutation
- BRCA2 Mutation
- Cardiovascular Diseases
- Cognitive Decline
- Menopause Surgical
- Quality of Life
- Surgical Menopause
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Cross-Sectional
Participation Requirements
- Age
- Between 55 years and 125 years
- Gender
- Only males
Description
Rationale: Women at high genetic risk of ovarian cancer are advised to undergo risk-reducing salpingo-oophorectomy (RRSO) at ages 35-45 years. Currently, in the Netherlands ~500 women/ year opt for RRSO, which minimizes ovarian cancer risk and may decrease breast cancer (BC) risk as well, due to red...
Rationale: Women at high genetic risk of ovarian cancer are advised to undergo risk-reducing salpingo-oophorectomy (RRSO) at ages 35-45 years. Currently, in the Netherlands ~500 women/ year opt for RRSO, which minimizes ovarian cancer risk and may decrease breast cancer (BC) risk as well, due to reduced gonadal hormone levels. Besides favorable effects of RRSO on ovarian cancer and, potentially, BC risk, RRSO induces immediate menopause, which may have unfavorable long-term health consequences. Early menopause has been associated with increased risks of cardiovascular disease (CVD), lower bone mineral density (BMD), cognitive impairment, and decreased quality of life. Current evidence regarding these health effects is mainly based on women with a natural early menopause, and it is unknown whether these results hold for women undergoing RRSO at early premenopausal ages. Objective: The investigators will investigate long-term health effects of premenopausal RRSO on (subclinical) cardiovascular status, BMD, cognition and quality of life. Study design: the investigators will assess long-term health effects of RRSO in a cross-sectional study, among 500 women who underwent premenopausal RRSO compared to 250 women of the same age without RRSO (or with RRSO after age 55). Eligible women will be invited to participate in a screening program assessing cardiovascular status, bone mineral density, cognitive functioning and quality of life. Study population: Women are eligible for the premenopausal RRSO group if: RRSO before the age of 45 years; RRSO was done 10 or more years ago; Women are eligible for the comparison group without premenopausal RRSO if the participant did not undergo RRSO before the age of 55 years, and did not have a natural or therapy induced menopause before age 50. Primary study outcome: To study long-term effects of premenopausal RRSO on: (subclinical) CVD BMD Cognition Secondary study outcome: To study long-term effects of premenopausal RRSO on: Quality of life Urogenital problems Cardiovascular risk factors Furthermore, the investigators will examine the influence of age at RRSO, time since RRSO, hormone replacement therapy (HRT), carrier ship of a BRCA1 or BRCA2 mutation and BC history on the outcome. The obtained knowledge will assist physicians in counselling women with high ovarian cancer risk and help them to make well-informed decisions.
Tracking Information
- NCT #
- NCT03835793
- Collaborators
- Dutch Cancer Society
- Erasmus Medical Center
- Radboud University
- Investigators
- Principal Investigator: Flora E van Leeuwen, Phd NKI-AvL