The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000082505
Ethics application status
Approved
Date submitted
24/01/2014
Date registered
2/02/2015
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Date results information initially provided
28/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in young high-risk women: A multicentre prospective study
Scientific title
A prospective study on the effects of risk-reducing bilateral salpingo-oophorectomy (RRBSO) in pre-menopausal women at risk of developing ovarian cancer on non-cancer outcomes including sexual function and menopause related quality of life.
Secondary ID [1] 281826 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
WHAM - Women's Health After surgical Menopause
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women at risk of developing ovarian and/or breast cancer who have undergone Risk Reducing Bilateral Salpingo-Oophorectomy (RRBSO) 288175 0
Condition category
Condition code
Cancer 288537 288537 0 0
Ovarian and primary peritoneal
Cancer 288538 288538 0 0
Breast
Reproductive Health and Childbirth 291614 291614 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 286380 0
Not applicable
Comparator / control treatment
Age matched control group participants who retain their ovaries and are not at increased risk of ovarian cancer will undergo the same processes as the identified high-risk group.
High risk group women who decide to delay RRBSO for at least 2 years will also be recruited to the comparison group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288697 0
Prospectively measure the effect of RRBSO on sexual function using validated questionnaires:
Fallowfield Sexual Activity Questionnaire (FSAQ)
Female Sexual Function Index (FSFI)
Female Sexual Distress Scale (revised) (FSDS-R)
Timepoint [1] 288697 0
2 years
Primary outcome [2] 291397 0
Prospectively measure effects of RRBSO on Menopausal quality of life using validated questionnaires:
Greene Climacteric Scale
Menopause Specific Quality of Life (MENQOL)
Timepoint [2] 291397 0
2 years
Primary outcome [3] 291398 0
Prospectively measure changes in bone turnover and bone density following RRBSO using serological markers and bone mineral density radiological scanning
Timepoint [3] 291398 0
2 years
Secondary outcome [1] 300777 0
Measure the uptake of Hormone Replacement Therapy in women undergoing RRBSO
Timepoint [1] 300777 0
2 years
Secondary outcome [2] 306670 0
Measure the effects of RRBSO on sleep quality using validated questionnaires:
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 306670 0
2 years
Secondary outcome [3] 306671 0
Measure the effects of RRBSO on cognitive function using a validated question and answer testing format:
Hopkins Verbal Learning Test
Symbol Digit Modality Test
Verbal Fluency Test
Timepoint [3] 306671 0
2 years
Secondary outcome [4] 306739 0
Measure the effects of RRBSO on anxiety and depresion using validated questionnaires:
Centre for Epidemiologic Studies Depression scale (CES-D)
Generalised Anxiety Disorder 7-item scale (GAD-7)
Timepoint [4] 306739 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 459 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 461 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 462 0
Westmead Hospital - Westmead
Recruitment hospital [4] 463 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 5063 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [6] 15354 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 28668 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 286609 0
Government body
Name [1] 286609 0
NHMRC
Address [1] 286609 0
GPO Box 1421
Canberra ACT 2601
Country [1] 286609 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street, Melbourne, VIC, 3000
Country
Australia
Secondary sponsor category [1] 285396 0
None
Name [1] 285396 0
Address [1] 285396 0
Country [1] 285396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288683 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 288683 0
Locked Bag 1 A'Beckett St
Victoria 8006
Ethics committee country [1] 288683 0
Australia
Date submitted for ethics approval [1] 288683 0
Approval date [1] 288683 0
04/12/2012
Ethics approval number [1] 288683 0
HREC/12/PMCC/24

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37274 0
Prof Martha Hickey
Address 37274 0
University of Melbourne Department of Obstetrics and Gynaecology
Level 7, Research Precinct
Royal Women's Hospital (RWH)
Cnr Grattan St & Flemington Rd
Parkville 3052 Victoria
Country 37274 0
Australia
Phone 37274 0
+613 8345 3719
Fax 37274 0
Email 37274 0
martha.hickey@thewomens.org.au
Contact person for public queries
Name 37275 0
Ms Research Coordinator
Address 37275 0
Level 7, Research Precinct
RWH
Cnr Grattan St & Flemington Rd
Parkville 3052 Victoria
Country 37275 0
Australia
Phone 37275 0
+613 8345 3719
Fax 37275 0
Email 37275 0
gynaecology.research@thewomens.org.au
Contact person for scientific queries
Name 37276 0
Prof Martha Hickey
Address 37276 0
University of Melbourne Department of Obstetrics and Gynaecology
Level 7, Research Precinct
RWH
Cnr Grattan St & Flemington Rd
Parkville 3052 Victoria
Country 37276 0
Australia
Phone 37276 0
+613 8345 3719
Fax 37276 0
Email 37276 0
martha.hickey@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary