Women with cervical cancer after radiation therapy
Conditions
Interventions
Treatment groups - The types of treatment for prevention of vaginal stenosis were divided into 4 groups. Three for topical treatment and one for the vaginal dilator that should be started after the en
D06.347.360
D04.808.054.079.429.824
D26.660
Sponsors
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher / Universidade Estadual de Campinas
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher / Universidade Estadual de Campinas
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Women aged 18-75 years with cervical cancer in treatment at the Radiotherapy Sector of the Women’s Hospital of the State University of Campinas; not using menopausal hormone therapy in the previous 6 months.
Exclusion criteria
Exclusion criteria: Explicit refusal to participate; Women who have contraindication to the use of topical estrogen, as follows: myocardial infarction, severe hypertension, uncontrolled diabetes mellitus, history of thromboembolic disease, uncontrolled liver disease, breast cancer, mammary atypical hyperplasia, genital bleeding of unknown origin), cholelithiasis); Women who have ulcerative colitis, Crohn's disease or diarrhea due to intestinal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of changes in vaginal volume after 12 months of treatment between the four groups, in order to know if any of the treatment groups has a greater effectiveness in the prevention of vaginal stenosis, ie, leads to a lower reduction in vaginal volume.;Comparison of the incidence of vaginal stenosis after 12 months according to the CTCAEv3.0 scale among the four treatment groups, aiming to know if any of the treatment groups has a greater effectiveness in the prevention of vaginal stenosis, ie, leads to a lower incidence of vaginal stenosis according to the CTCAEv3.0 scale after 12 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of change in quality of life after 12 months of initiation of treatment among the four treatment groups. For this purpose, the WHOQOL-bref questionnaire, which has already been validated for Portuguese, will be used.;Comparison of change in sexual function after 12 months of initiation of treatment among the four treatment groups. For this purpose, the FSFI (Female Sexual Function Index) questionnaire will be used, both in its total score and in the different domains of sexual function. This questionnaire was already validated for Portuguese.;Comparison of the change in vaginal trophism after 12 months of initiation of treatment between the four treatment groups, in order to know if any of the treatment groups have a greater influence on the vaginal mucosa. In order to do so, the hormonal vaginal cytology will be used, with the calculation of the vaginal maturation index (Meisels Index).;Comparison of the change in overall vaginal health after 12 months of initiation of treatment among the four treatment groups, in order to know if any of the treatment groups have greater influence on various aspects of vaginal health. To do so, the vaginal health index score (VHIS) will be used, which takes into account aspects such as overall elasticity, pH, vaginal secretion and humidity. | — |
Countries
Brazil
Contacts
Public ContactLuiz Cintra Baccaro
Hospital da Mulher Professor Doutor José Aristodemo Pinotti - Centro de Atenção Integral à Saúde da Mulher / Universidade Estadual de Campinas
Outcome results
None listed