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Randomized Controlled Trial
. 2021 Jun 10;21(1):682.
doi: 10.1186/s12885-021-08274-w.

Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial

Jumara Martins  1 , Ana Francisca Vaz  1 , Regina Celia Grion  1 , Lúcia Costa-Paiva  2 , Luiz Francisco Baccaro  3
Affiliations
Randomized Controlled Trial

Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial

Jumara Martins et al. BMC Cancer. .

Erratum in

Abstract

Background: 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.

Methods: open-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.

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. 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 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 registration: Brazilian Registry of Clinical Trials, RBR-23w5fv . Registered 10 January 2017 - Retrospectively registered.

Keywords: Adverse effects; Brachytherapy; Radiotherapy; Uterine cervical neoplasm.

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Conflict of interest statement

The authors have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Study population between 2013 and 2018
Fig. 2
Fig. 2
Vaginal stenosis (CTCAE v3.0 scale) in the different groups during follow-up (n = 142)
Fig. 3
Fig. 3
Change in vaginal volume (%) in the different groups during follow-up (n = 142)
See this image and copyright information in PMC

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