A Multicentre Prospective Study to Investigate the Prevalence of Sexual Dysfunction and Quality of Life in Women with Breast Cancer receiving Aromatase Inhibitors (ACTRN12607000068460)
A Multicentre Prospective Study to Investigate the Prevalence of Sexual Dysfunction and Quality of Life in Women with Breast Cancer receiving Aromatase Inhibitors
Observational
Phase not listed
Investigative Site
Sponsor: Professor Michael Friedlander
Last Updated: January 21, 2007 Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.
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.
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.
Do you think this trial is incorrectly appearing?
Design Details
AllocationN/A
Intervention ModelN/A
MaskingN/A
Number to Enroll200
Arms & Interventions
Arms
Interventions
No interventions available.
Outcome Measures
Primary Outcome Measures
At baseline and at 3 and 6 months after commencing on aromatase inhibitors.
Sexual activity questionnaire
Secondary Outcome Measures
Dyspareunia – visual analog scaleAt baseline and at 3 and 6 months after commencing on aromatase inhibitors.