Status:
COMPLETED
Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment
Lead Sponsor:
Centro de Atenção ao Assoalho Pélvico
Conditions:
Atrophy;Vaginal
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic...
Detailed Description
The Genitourinary Menopause Syndrome (MMS) affects up to 70% of in treatment breast cancer patients. Symptoms are due to a decrease in hormone levels or block to circulating hormones and induce functi...
Eligibility Criteria
Inclusion
- 18-65 anos
- Pathological proven Breast Cancer diagnosis
- Stage 0-III by American Joint Committee on Cancer (AJCC) and International Union Against Cancer (UICC) of Classification of Malignant Tumours, TNM (Acronym for Tumor-Node-Metastasis) 8ª edition
- Genitourinary Syndrome of Menopause confirmed through patient-reported symptoms and gynecological examination (of external structures, introitus, and vaginal mucosa)
- Vaginal pH \>5,0
Exclusion
- Hormone replacement less than 6 months
- Diagnosis of vaginal infection
- Difficulty in understanding the proposed instruments
- Patients with chronic neurological degenerative diseases that preclude to be on position
- Metastatic disease
- Any vaginal photodynamic treatment less than 3 months
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03833726
Start Date
January 30 2019
End Date
September 30 2023
Last Update
December 5 2023
Active Locations (1)
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1
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, Brazil, 40.290-000