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Breast Cancer Survivors with Genitourinary Syndrome benefit from vaginal treatment with Erbium Laser: clinical and histological findings

Use of Erbium Yag Laser in the treatment of Vulvovaginal Atrophy in women survivors of Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10xxmhs3
Enrollment
Unknown
Registered
2025-09-02
Start date
2024-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitalia, Female

Interventions

This is a prospective, non-randomized, single-arm clinical study, designed as a pilot project, involving 13 breast cancer survivors, all diagnosed with genitourinary syndrome of menopause (GSM). The s

Sponsors

Centro de Pós-Graduação da Ciências Médicas de Minas Gerais – Faculdade de Ciências Médicas
Lead Sponsor
Centro de Pós-Graduação da Ciências Médicas de Minas Gerais – Faculdade de Ciências Médicas
Collaborator

Eligibility

Sex/Gender
Female
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Women patient aged between 30 and 70 years.History of hormone-dependent breast cancer and use of hormone blockers. End of chemotherapy treatment.Patients who give their informed consent to take part in the study.Patients with at least 3 symptoms of genitourinary menopausal syndrome (GMS)

Exclusion criteria

Exclusion criteria: Patients who do not wish to have their data used in the study.Patients who refuse to undergo biopsy and cytological examination before or after treatment.Patients under 30 and over 70.Patients undergoing chemotherapy.Pregnant and breastfeeding women.Patients who do not have at least 3 symptoms of genitourinary menopausal syndrome (GMS).Patients who have already undergone previous vaginal laser treatment

Design outcomes

Primary

MeasureTime frame
Primary outcome: at the end of the study, a vaginal health index of more than 15 and a score on the symptom intensity questionnaire of less than 10 are expected, reflecting a normal vaginal mucosa

Secondary

MeasureTime frame
With the improvement in vaginal health, it is expected that there will be an improvement in sexual health as assessed by the FSFI and patient satisfaction with the treatment as assessed by the likert scale

Countries

Brazil

Contacts

Public ContactKeila Ferreira

Keila Seabra Dermatology Clinic

keila.teles@hotmail.com+55(35)999472099

Outcome results

None listed

Source: REBEC (via WHO ICTRP)