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A Multicentre Prospective Study to Investigate the Prevalence of Sexual Dysfunction and Quality of Life in Women with Breast Cancer receiving Aromatase Inhibitors

A Multicentre Prospective Study to Investigate the Prevalence of Sexual Dysfunction and Quality of Life in Women with Breast Cancer receiving Aromatase Inhibitors

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12607000068460
Enrollment
200
Registered
2007-01-22
Start date
2007-03-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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).Thes

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.

Sponsors

Professor Michael Friedlander
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Diagnosis of metastatic breast cancer.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026