Breast Neoplasms
Conditions
Interventions
Prospective, randomized, single-blinded, controlled study with three parallel arms. Experimental group: 34 breast cancer survivors with Genitourinary Menopause Syndrome will receive three vaginal appl
Sponsors
Universidade Federal do Rio Grande do Norte
Universidade Federal do Rio Grande do Norte
Eligibility
Sex/Gender
Female
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Women with nonmetastatic breast cancer; age 45 to 65 years; sexually active; with genitourinary symptoms
Exclusion criteria
Exclusion criteria: Women with recurrent or metastatic cancer; prior reconstructive pelvic surgery for prolapse; use any form of hormonal therapy in the last six months; use of lubricants or moisturizers in the past month; the presence of genital infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the parameters of sexual function and quality of life is expected within a year, verified through updated and validated tests in Portuguese of the Female Sexual Function Index (FSFI) and a Short version of an instrument that evaluates the physical and mental health (A Short Form Health Survey SF-12), based on the verification of a variation of at least 30% in the pre-and post-intervention sessions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the parameters of vaginal atrophy (vaginal pain, burning, itching, dryness, dyspareunia, and dysuria) is expected within one year, verified using the 10-point Visual Analog Scale (VAS); Vaginal Health (epithelial integrity, vaginal elasticity, humidity, fluid volume, and vaginal pH), using the Vaginal Health Index (VHI), based on the verification of a variation of at least 30% in pre- and post-intervention measurements. | — |
Countries
Brazil
Contacts
Public ContactNicoli Azevedo
Univesidade Federal do Rio Grande do Norte
Outcome results
None listed