Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000068460
Ethics application status
Not yet submitted
Date submitted
16/01/2007
Date registered
22/01/2007
Date last updated
22/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A Multicentre Prospective Study to Investigate the Prevalence of Sexual Dysfunction and Quality of Life in Women with Breast Cancer receiving Aromatase Inhibitors
Scientific title
A Multicentre Prospective Study to Investigate the Prevalence of Sexual Dysfunction and Quality of Life in Women with Breast Cancer receiving Aromatase Inhibitors
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual Dysfunction 1559 0
Breast Cancer 1560 0
Condition category
Condition code
Cancer 1659 1659 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The primary outcome is sexual functioning and of interest is the report of vaginal dryness, dyspareunia (painful sexual intercourse) and sexual satisfaction. This will be measured with validated questionnaires at baseline (prior to treatment with aromatase inhibitors), at 3 months and at 6 months. The duration of observation is 6 months.
Participants will include women with a diagnosis of breast cancer who are menopausal at the time of recruitment (ie no menstruation for at least 6 months).These are women who will be receiving recommended treatment with aromatase inhibitors (not a trial intervention but routine treatment). Many breast tumours are "oestrogen sensitive," meaning the hormone oestrogen helps them to grow. Aromatase inhibitors can help slow or stop the growth of these tumours by lowering the amount of oestrogen in the body.
Intervention code [1] 1561 0
Lifestyle
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2298 0
Sexual activity questionnaire
Timepoint [1] 2298 0
At baseline and at 3 and 6 months after commencing on aromatase inhibitors.
Secondary outcome [1] 4005 0
Dyspareunia – visual analog scale
Timepoint [1] 4005 0
At baseline and at 3 and 6 months after commencing on aromatase inhibitors.
Secondary outcome [2] 4006 0
Quality of life (Functional Assessment of Cancer Therapy - Breast (FACT-B).
Timepoint [2] 4006 0
At baseline and at 3 and 6 months after commencing on aromatase inhibitors.
Secondary outcome [3] 4007 0
Vaginal dryness (Functional Assessment of Cancer Therapy – endocrine symtpoms (FACT-ES)
Timepoint [3] 4007 0
At baseline and at 3 and 6 months after commencing on aromatase inhibitors.

Eligibility
Key inclusion criteria
Primary breast cancer. Post-menopausal (no menstrual periods for at least 6 months). 6-8 weeks post chemotherapy Not receiving adjuvant anti-oestrogen therapy at time of study entry Fluent in English Willingness to complete questionnaire.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of metastatic breast cancer.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1806 0
Charities/Societies/Foundations
Name [1] 1806 0
Susan G Komen Foundation
Country [1] 1806 0
Primary sponsor type
Individual
Name
Professor Michael Friedlander
Address
Country
Secondary sponsor category [1] 1626 0
None
Name [1] 1626 0
Nil
Address [1] 1626 0
Country [1] 1626 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3372 0
Northern Sydney Central Coast Health Coast Human Research Ethics Committee
Ethics committee address [1] 3372 0
Ethics committee country [1] 3372 0
Australia
Date submitted for ethics approval [1] 3372 0
Approval date [1] 3372 0
Ethics approval number [1] 3372 0
Ethics committee name [2] 3373 0
South Eastern Sydney/Illawarra Area Health Service Human Research Ethics Committee - Northern Section
Ethics committee address [2] 3373 0
Ethics committee country [2] 3373 0
Australia
Date submitted for ethics approval [2] 3373 0
Approval date [2] 3373 0
Ethics approval number [2] 3373 0
Ethics committee name [3] 3374 0
Redcliffe-Caboolture Health Service District Ethics Committee
Ethics committee address [3] 3374 0
Ethics committee country [3] 3374 0
Australia
Date submitted for ethics approval [3] 3374 0
Approval date [3] 3374 0
Ethics approval number [3] 3374 0
Ethics committee name [4] 3375 0
Central Northern Adelaide Health Services Ethics of Human Research Committee (TQEH & LMH)
Ethics committee address [4] 3375 0
Ethics committee country [4] 3375 0
Australia
Date submitted for ethics approval [4] 3375 0
Approval date [4] 3375 0
Ethics approval number [4] 3375 0
Ethics committee name [5] 3376 0
Royal Perth Hospital Ethics Committee
Ethics committee address [5] 3376 0
Ethics committee country [5] 3376 0
Australia
Date submitted for ethics approval [5] 3376 0
Approval date [5] 3376 0
Ethics approval number [5] 3376 0
Ethics committee name [6] 3377 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [6] 3377 0
Ethics committee country [6] 3377 0
Australia
Date submitted for ethics approval [6] 3377 0
Approval date [6] 3377 0
Ethics approval number [6] 3377 0
Ethics committee name [7] 3378 0
Eastern Health Research and Ethics Committee
Ethics committee address [7] 3378 0
Ethics committee country [7] 3378 0
Australia
Date submitted for ethics approval [7] 3378 0
Approval date [7] 3378 0
Ethics approval number [7] 3378 0
Ethics committee name [8] 3379 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [8] 3379 0
Ethics committee country [8] 3379 0
Australia
Date submitted for ethics approval [8] 3379 0
Approval date [8] 3379 0
Ethics approval number [8] 3379 0
Ethics committee name [9] 3380 0
Peninsula Health Research & Ethics Committee
Ethics committee address [9] 3380 0
Ethics committee country [9] 3380 0
Australia
Date submitted for ethics approval [9] 3380 0
Approval date [9] 3380 0
Ethics approval number [9] 3380 0

Summary
Brief summary
Whilst the long-term effects of chemotherapy and hormonal therapy with tamoxifen on sexual function and quality of life of women with breast cancer has been well documented, less is known about the impact of aromatase inhibitors (AIs) on a woman’s sexual functioning. Common sexual issues raised have included vaginal dryness, painful sexual intercourse (dyspareunia) and a reduction in libido. AIs have largely replaced tamoxifen as choice of hormonal treatment in post-menopausal women and as there will an increasing number of women on AIs, it is important to document the impact of AI use on sexual functioning. The result of this study will raise the awareness of the potential effects of AI use and sexual dysfunction for both the physician and patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27495 0
Address 27495 0
Country 27495 0
Phone 27495 0
Fax 27495 0
Email 27495 0
Contact person for public queries
Name 10750 0
Dr Kelly Mok
Address 10750 0
Psychosocial Research Group
Prince of Wales Hospital
Lvl 3 Dickinson Bldg
Barker St
Randwick NSW 2031
Country 10750 0
Australia
Phone 10750 0
+61 2 93823371
Fax 10750 0
Email 10750 0
[email protected]
Contact person for scientific queries
Name 1678 0
Professor Micahel Friedlander
Address 1678 0
Psychosocial Research Group
Prince of Wales Hospital
Lvl 3 Dickinson Bldg
Barker St
Randwick NSW 2031
Country 1678 0
Australia
Phone 1678 0
+61 2 93822586
Fax 1678 0
Email 1678 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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