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87 Clinical trial with topical use of estrogen, testosterone and vaginal dilator in the prevention of vaginal stenosis in women with cervical cancer after radiotherapy

Objectives To compare the efficacy of topical estrogen, testosterone and vaginal dilator in the prevention/treatment of vaginal stenosis in women with cervical cancer after radiotherapy. Methods Clinical trial of 195 women referred for radiotherapy at a university hospital from 01/2013 to 05/2018, randomized to receive topical estrogen (66), topical testosterone (34), vaginal dilator (29) or lubricating gel (66) for one year, starting soon after the end of radiotherapy. The outcome variable was vaginal stenosis assessed using the Common Terminology Criteria Adverse Events (CTCAE) scale and percental changes in vaginal volume. Evaluations were performed shortly after radiotherapy, 4 months, 8 months and one year after treatment. Statistical analysis was carried out using Symmetry and Kruskal-Wallis tests. Results The mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period (figure 1). Abstract 87 Figure 1 Vaginal volume variation (%) in the different groups throughout the intervention period (n=142) There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p<0.01), except for the users of vaginal dilator (p=0.37). Conclusions There was a reduction in vaginal volume in all groups, with no significant difference between the different types of treatment. However, women who used a vaginal dilator had a lower incidence of vaginal stenosis evaluated by the CTCAE scale after 1 year of treatment.