Randomized clinical trial, with topical estrogen use, testosterone therapy and vaginal dilator in the prevention of vaginal stenosis in women with cervical carcinoma after radiation therapy

• Grant number: 12/09215-7
• Support Opportunities: Regular Research Grants
• Start date: December 01, 2012
• End date: November 30, 2017
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Luiz Francisco Cintra Baccaro
• Grantee: Luiz Francisco Cintra Baccaro
• 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: Ana Francisca Vaz

Abstract

To compare the efficacy of topical estrogen use, testosterone therapy and vaginal dilator in the treatment of vaginal stenosis, and assess its interference in sexual function and quality of life (QOL) in women with cervical carcinoma undergoing radiation therapy (RT). Methods: A randomized clinical trial will be conducted, based on 254 women with cervical carcinoma, ranging in age from 18 to 75 years, referred for radiation therapy in the Radiotherapy Division of the Prof. Dr. José Aristodemo Pinotti Women's Hospital, CAISM/UNICAMP. Women will be selected and randomized into four groups, three groups will receive topical treatment with a tablet inserted vaginally (one estrogen group, one testosterone group and one control group receiving placebo-KY® gel), and the remaining group shall use the vaginal dilator for one year starting at the end of RT. Women will respond to a questionnaire developed for data collection before starting RT. Symptoms related to vaginal stenosis will be graded according to the Common Terminology Criteria Adverse Event severity grading scale (CTCAE) v 3.0, sexual function will be assessed by the FSFI (Female Sexual Function Index) questionnaire and QOL will be assessed by the WHOQOL - BREF questionnaire used during nursing consultation, before the beginning of RT, at the end of RT, at 4 months, at 8 months and one year after treatment. In addition to vaginal stenosis, vaginal trophism, cytology, vaginal pH and serum levels of estradiol, total and free testosterone, follicle-stimulating hormone (FSH), androstenedione, dehydroepiandrosterone, dehydroepiandrosterone sulfate, and sex hormone-binding globulin (SHBG) will be evaluated. Statistical analysis shall be performed by using the chi-square test, Student's t-test and the Wilcoxon test, univariate and multivariate analysis. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

MARTINS, JUMARA; VAZ, ANA FRANCISCA; GRION, REGINA CELIA; COSTA-PAIVA, LUCIA; BACCARO, LUIZ FRANCISCO. Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial. BMC CANCER, v. 21, n. 1, JUN 10 2021. (12/09215-7)

GRION, REGINA CELIA; BACCARO, LUIZ FRANCISCO; VAZ, ANA FRANCISCA; COSTA-PAIVA, LUCIA; CONDE, DELIO MARQUES; PINTO-NETO, AARAO MENDES. Sexual function and quality of life in women with cervical cancer before radiotherapy: a pilot study. ARCHIVES OF GYNECOLOGY AND OBSTETRICS, v. 293, n. 4, p. 879-886, APR 2016. (12/09215-7)

MARTINS, JUMARA; VAZ, ANA FRANCISCA; GRION, REGINA CELIA; BARROS ESTEVES, SERGIO CARLOS; COSTA-PAIVA, LUCIA; BACCARO, LUIZ FRANCISCO. Factors associated with changes in vaginal length and diameter during pelvic radiotherapy for cervical cancer. ARCHIVES OF GYNECOLOGY AND OBSTETRICS, v. 296, n. 6, p. 1125-1133, DEC 2017. (12/09215-7)