Effect of non-hormonal vaginal moisturizer gel on vaginal and sexual health in postmenopausal women with Breast Cancer: a randomized clinical trial

Abstract

To evaluate the effect of non-hormonal vaginal moisturizer gel on the vaginal and sexual health of postmenopausal women with breast cancer. Secondary objectives: Subproject 1: to evaluate the effectiveness of non-hormonal vaginal moisturizer gel on vaginal symptoms of genitourinary syndrome in postmenopausal women with breast cancer; Subproject 2: to evaluate the impact of non-hormonal vaginal moisturizer gel on the sexual function of postmenopausal women with breast cancer; Subproject 3: to evaluate the effect of non-hormonal vaginal moisturizer gel on the vaginal microbiome of postmenopausal women with breast cancer. Methods: A single-center randomized, open-label, controlled clinical trial will be performed. And 100 women will be included with the date of the last menstruation e 12 months, age 45-65 years, histological diagnosis of breast cancer and who completed cancer treatment (surgery, chemotherapy or radiotherapy), except adjuvant endocrine therapy, in stage I, II or III and with vaginal symptoms (vaginal dryness and/or dyspareunia). And those with stage IV and/or metastatic disease, in the presence of radiotherapy or chemotherapy, alcoholic or drug addicts, current use of vaginal moisturizers or vaginal estrogen in the previous six months, lower genital tract infection and cognitive impairment will be excluded. Participants will be randomized into two groups: study group, vaginal moisturizing gel (n=50) or control group, vaginal lubricant (n=50). The intervention time will be 16 weeks, with an initial inclusion visit (V1), a follow-up visit (V2, with 8 weeks) and a final visit (V3). In V1, the Vaginal Assessment Scale (VAS, Vaginal Assessment Scale) and the Female Sexual Function Index (FSFI) will be applied, and a gynecological examination will be performed to assess the Vaginal Health Index (VHI, Vaginal Health Index Score), measure the pH vaginal and collect slides for Vaginal Maturation Index (VMI) and Gram and perform vaginal washing for microbiome analysis. During this visit, the user will be advised to use a vaginal moisturizing gel composed of sodium hyaluronate and polycarbophil, vaginally, at night, 3x/week, with the product being delivered for eight weeks, or the use of a water-based vaginal lubricant during sexual activity. In visit V2, the VHI and vaginal pH will be performed, and the products will be delivered for the next 8 weeks. The final visit (V3) will be after 16 weeks of the initial visit and the VAS and FSFI will be applied and a gynecological examination will be performed to assess the VHI, measure the vaginal pH and collect the IMV and Gram and perform a vaginal wash for microbiome analysis. Adherence and adverse events will be evaluated at all visits until the end of the study. (AU)