The effectiveness of topical Estradiol, Vaginal Dilators or a combination of both in preventing vaginal stenosis after Radiotherapy for the treatment of cervical cancer

Phase 2

• Conditions: Other noninflammatory disorders of vagina; Menopause; E02.186.775

• Registration Number: RBR-2258hp5
• Lead Sponsor: niversidade Estadual de Campinas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-24
• Last Update Posted: 22 July 2024
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women diagnosed with cervical cancer with disease stage I to IIIC2, who are recommended to undergo pelvic Radiotherapy treatment.

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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