None listed
Conditions
Brief summary
The study is evaluating the impact of risk-reducing bilateral salpingo-oophorectomy (RRBSO) on sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function in high-risk, pre-menopausal women. Who is it for? You may be eligible to join this study if you are aged between 18 years old (inclusive) and 50 years old (inclusive), at a high risk of developing breast and/or ovarian cancer, have regular menstrual periods if your uterus is intact, no current vasomotor symptoms (e.g. hot flushes and night sweats), early follicular follicle-stimulation hormone (FSH) of equal to or less than 15 IU/L, Estradiol > 100pmol/L, and are planning to have RRBSO. Women who are not planning to have RRBSO or become pregnant in the next 2 years, and fit the same eligibility criteria are also asked to participate. They will form an age matched control. Trial design. Participants in this study will be required to undergo blood tests and bone mineral density scanning at baseline and then repeated on an annual basis for 2 years. Participants will also need to complete questionnaires relating to sexual function, menopause, depression/anxiety, and sleep quality at baseline, 3 months, 6 months, 12 months and 24 months. Participants will also have tests to measure cognitive function at baseline, 3 months, 12 months and 24 months.
Interventions
Women at risk of developing ovarian and/or breast cancer who have undergone RRBSO. Non-cancer outcomes including sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function will be assessed using the following: Blood tests performed at baseline, 12 & 24 months. Time required = 1/2 hour x 3 episodes. Total time =1 and 1/2 hours Bone mineral density scanning x 3 occasions (baseline, 12 and 24 months) at 1 hour each. Total time = 3 hours. Completion of questionnaires (N=8) x 5 occasions (baseline, 3, 6, 12 and 24 months) at 1/2 hour each. Total time = 2 hours. Short question and answer tests to measure cognitive function x 3 occasions (baseline, 12 and 24 months) at 45 mins each. Total time = 2 and 1/4 hours.
Sponsors
Eligibility
Inclusion criteria
Aged 18 - 50 years Regular menstrual periods (if intact uterus) No current vasomotor symptoms (hot flushes and night sweats) Early follicular FSH of equal to or less than 15 UI/L Estradiol > 100 pmol/L At a high risk of developing breast and/or ovarian cancer Planning to undergo RRBSO
Exclusion criteria
Previous bilateral salpingo-oophorectomy Taking anti-estrogen agents or tamoxifen in the previous 3 months Lactating or within 3 months of pregnancy English non-speakers Undiagnosed abnormal vaginal bleeding Current pregnancy (to be excluded with pregnancy test where indicated)