Objectives With improved survival rates for locally advanced cervical cancer, research focus has shifted to treatment-related adverse events. A clinical trial was conducted to compare the effects of topical estrogen, topical testosterone and vaginal dilator in QOL of women after radiotherapy.

Methods Clinical trial of 195 women, 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 from 01/2013 to 05/2018. The outcome variable was QOL evaluated by WHOQOL-bref. Evaluations were performed shortly after radiotherapy (afterRT), 4 months (4m), 8 months (8m) and one year after treatment (12m). Statistical analysis was carried out using ANOVA and multiple linear regression.

Results The mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. No changes were observed in the different WHOQOL-bref domains for the different treatment groups during the intervention period, except for the physical domain, where a significant improvement of the mean score was observed in the testosterone (after RT≠8m,12m; 4m ≠ 8m; p<0.01) and vaginal dilator group (after RT≠8m,12m; p<0.01). Multiple linear regression was performed to evaluate the factors associated with the percentual change in the WHOQOL-bref scores after 12 months of intervention. Having received teletherapy and brachytherapy (β=38.09, p<0.01) and using a vaginal dilator (β=24.43; p=0.01) were independent factors associated with an improvement in the physical domain of WHOQOL-bref.

Conclusions Women who used a vaginal dilator showed improvement in the physical domain of QOL after 12 months of intervention.