Other noninflammatory disorders of vagina
Conditions
Interventions
A randomized clinical trial will be conducted with 120 women diagnosed with cervical cancer treated with Radiotherapy. The women will be randomized into three groups: in group 1, the women (n=40) will
those in group 2 (n=40) will receive 1 tablet of 10 mcg of hemi-hydrated estradiol twice a week combined with a vaginal dilator (used three times a week for 10 minutes each time)
and those in group 3 (n=40) will receive a vaginal dilator (used three times a week for 10 minutes each time), for two years starting at the end of Radiotherapy. The randomization will be conducted us
Sponsors
Universidade Estadual de Campinas
Universidade Estadual de Campinas
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Women diagnosed with cervical cancer with disease stage I to IIIC2, who are recommended to undergo pelvic Radiotherapy treatment.
Exclusion criteria
Exclusion criteria: Age under 18 or over 75 years old; use of hormonal therapy in the three months prior to inclusion; previous pelvic radiotherapy treatment; refuse to participate in the study; be under treatment or have been treated for breast or endometrial cancer from the time of inclusion; suspicion of neoplasm or hormone-dependent precursor lesion during study follow-up; personal history of thromboembolism or diagnosis of thrombophilia; current or recent history (less than 6 months) of angina or stroke or myocardial infarction; active liver disease; hypersensitivity to the components of the medications used in the study or the orthosis (dilator); porphyria; neurological diseases disabling the ability to follow study instructions; use of an implanted ferromagnetic defibrillator or pacemaker and cochlear implant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a lower degree of stenosis after radiotherapy treatment in women using topical estrogen associated with a vaginal dilator, when compared to those using estrogen alone or an isolated vaginal dilator. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that a lower number of women who will use topical estrogen associated with a vaginal dilator will experience sexual dysfunction (measured through a questionnaire that assesses female sexual function) when compared to those who will use topical estrogen alone or an isolated vaginal dilator.;It is expected that women who will use topical estrogen associated with a vaginal dilator will have quality of life levels (measured through a questionnaire) similar to women who will use topical estrogen alone or an isolated vaginal dilator.;The use of topical estrogen for 2 years is expected to be safe and not cause endometrial changes | — |
Countries
Brazil
Contacts
Public ContactAdriana Yoshida
Universidade Estadual de Campinas
Outcome results
None listed