Randomized clinical trial on the use of topical estradiol, vaginal dilator, and their combination in the prevention of vaginal stenosis in women with cervical cancer after radiotherapy treatment.

• Grant number: 24/21452-1
• Support Opportunities: Regular Research Grants
• Start date: May 01, 2025
• End date: April 30, 2028
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Luís Otávio Zanatta Sarian
• Grantee: Luís Otávio Zanatta Sarian
• Host Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
• Associated researchers: Adriana Yoshida ; Luiz Francisco Cintra Baccaro

Abstract

Study Design: This is a randomized clinical trial aimed at comparing the efficacy of topical estradiol, a vaginal dilator, and the combination of both in treating vaginal stenosis in women with cervical cancer who have undergone radiotherapy.Methods: The study will include 120 women aged 18 to 75 years with cervical cancer, referred for treatment at the Radiotherapy Section of the Prof. Dr. José Aristodemo Pinotti Women's Hospital (CAISM/Unicamp). The participants will be randomized into three groups: vaginal dilator use, topical estrogen use, or the combined use of vaginal dilator and topical estrogen, to be administered for two years starting after the completion of radiotherapy.Participants will complete a clinical data questionnaire before starting radiotherapy. Symptoms related to vaginal stenosis will be graded using the Late Effects of Normal Tissues, Subjective, Objective, Management (LENT/SOMA) scale. The degree of stenosis will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 scale and vaginal volume measurements. Vaginal atrophy will be evaluated through vaginal cytology and the Vaginal Health Index (VHI). Sexual function will be assessed using the Female Sexual Function Index (FSFI) questionnaire, and quality of life will be evaluated using the Functional Assessment of Cancer Therapy-Cervix (FACT-CX) questionnaire.Transvaginal ultrasound will be performed on participants using topical estrogen to evaluate endometrial thickness and content before initiating the topical medication and at 12, 18, and 24 months after starting the treatment.Statistical analysis will be conducted using the chi-square or Fisher's exact test and the Kruskal-Wallis test. Univariate and multivariate logistic regression analyses will also be performed. (AU)