Abstract
BackgroundWe aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer.Methodsopen-label randomized clinical trial of 195 women, stage I-IIIB, aged 18–75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression.Resultsthe 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. 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).Conclusionsthere was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment.Trial registrationBrazilian Registry of Clinical Trials, RBR-23w5fv. Registered 10 January 2017 - Retrospectively registered.
Highlights
Cervical cancer is the fourth commonest cancer in women worldwide [1]
Subject selection Women with cervical cancer, stage I to IIIB according to the International Federation of Gynecology and Obstetrics [26], aged between 18 and 75 years, who had not undergone hormone therapy in the previous 6 months and who intended undergoing all radiotherapy treatment at the hospital, were invited to participate
Vaginal stenosis is a common adverse event following pelvic radiotherapy in women treated for cervical cancer
Summary
Cervical cancer is the fourth commonest cancer in women worldwide [1]. In Brazil, incidence and mortality rates are intermediate in terms of developing countries, but high compared to those in developed countries with wellstructured early-detection programs [1,2,3,4]. According to the Sedlis criteria, the initial standard treatment is surgery associated with radiotherapy; and for more advanced cases, the standard therapy comprises concomitant radiotherapy and chemotherapy [5]. With increased survival rates of women with cervical cancer, there is an increase in late treatment-related adverse events. Vaginal stenosis, defined as decreased diameter and/or length of the vagina, is one of the most frequent (59–88%) and may be multifactorial in origin [9,10,11,12]. Ionizing therapy leads to decreased blood supply, loss of collagen and elasticity, and associated tissue fibrosis, especially in women treated with high doses [10, 13] and associated chemotherapy [14]. We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer
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