Impact of risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in young high-risk women: A multicentre prospective study

Not Applicable

Completed

• Conditions: Women at risk of developing ovarian and/or breast cancer who have undergone Risk Reducing Bilateral Salpingo-Oophorectomy (RRBSO); Cancer - Ovarian and primary peritoneal; Cancer - Breast; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12615000082505
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-02
• Study Completion: 2021-02-03
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 224

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prospectively measure the effect of RRBSO on sexual function using validated questionnaires:<br>Fallowfield Sexual Activity Questionnaire (FSAQ)<br>Female Sexual Function Index (FSFI)<br>Female Sexual Distress Scale (revised) (FSDS-R)[2 years];Prospectively measure effects of RRBSO on Menopausal quality of life using validated questionnaires:<br>Greene Climacteric Scale<br>Menopause Specific Quality of Life (MENQOL)[2 years];Prospectively measure changes in bone turnover and bone density following RRBSO using serological markers and bone mineral density radiological scanning[2 years]

Secondary Outcome Measures

Name	Time	Method
Measure the uptake of Hormone Replacement Therapy in women undergoing RRBSO[2 years];Measure the effects of RRBSO on sleep quality using validated questionnaires:<br>Pittsburgh Sleep Quality Index (PSQI)[2 years];Measure the effects of RRBSO on cognitive function using a validated question and answer testing format:<br>Hopkins Verbal Learning Test<br>Symbol Digit Modality Test<br>Verbal Fluency Test[2 years];Measure the effects of RRBSO on anxiety and depresion using validated questionnaires:<br>Centre for Epidemiologic Studies Depression scale (CES-D)<br>Generalised Anxiety Disorder 7-item scale (GAD-7)[2 years]