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Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial.
- Source :
-
BMC cancer [BMC Cancer] 2021 Jun 10; Vol. 21 (1), pp. 682. Date of Electronic Publication: 2021 Jun 10. - Publication Year :
- 2021
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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.<br />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.<br />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).<br />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.<br />Trial Registration: Brazilian Registry of Clinical Trials, RBR-23w5fv . Registered 10 January 2017 - Retrospectively registered.
- Subjects :
- Administration, Topical
Adolescent
Adult
Aged
Brazil epidemiology
Chemoradiotherapy methods
Constriction, Pathologic diagnosis
Constriction, Pathologic epidemiology
Constriction, Pathologic etiology
Constriction, Pathologic prevention & control
Dilatation instrumentation
Dilatation methods
Estrogens, Conjugated (USP) administration & dosage
Female
Humans
Incidence
Middle Aged
Neoplasm Staging
Radiation Injuries diagnosis
Radiation Injuries etiology
Radiation Injuries prevention & control
Severity of Illness Index
Testosterone Propionate administration & dosage
Treatment Outcome
Uterine Cervical Neoplasms diagnosis
Uterine Cervical Neoplasms pathology
Vagina drug effects
Vagina pathology
Vagina radiation effects
Vaginal Diseases diagnosis
Vaginal Diseases etiology
Vaginal Diseases prevention & control
Young Adult
Brachytherapy adverse effects
Chemoradiotherapy adverse effects
Radiation Injuries epidemiology
Uterine Cervical Neoplasms radiotherapy
Vaginal Diseases epidemiology
Subjects
Details
- Language :
- English
- ISSN :
- 1471-2407
- Volume :
- 21
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- BMC cancer
- Publication Type :
- Academic Journal
- Accession number :
- 34112100
- Full Text :
- https://doi.org/10.1186/s12885-021-08274-w