Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment

Study Overview
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Brief Summary
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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 treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse.

Detailed Description
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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 functional changes in the vagina cutting in quality of life and impacting sexual function. This is a randomized, double blind trial in a sample of 74 individuals that will be performed at an specialized Pelvic Floor Care Center (CAAP) in Brazil. Will be included women age between 18 and 65 years, in adjuvant hormone therapy, with clinical signs and symptoms of vulvovaginal atrophy syndrome and cytologic evidence of atrophy, (pH <5.0 and vaginal cytology with predominance of superficial cells). Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, pregnant women, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases. Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them compared with sham procedure, and both groups will perform five sessions of kinesiotherapy sessions. Maturation vaginal index will be checked before and after all treatment and self- administered questionnaires will be performed before each session with Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7), International Consultation on Incontinence Questionnaire - Short Form, (ICIQ-SF), Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B). At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction

Official Title
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Light Emitting Diode for the Treatment of Genitourinary Syndrome of Menopause Associated With Hormonal Therapy for Treating Breast Cancer: Randomized Controlled Clinical Trial

Conditions
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Atrophy;Vaginal, Breast Cancer

Intervention / Treatment
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* Procedure: Experimental: LED group
* Procedure: Sham Comparator: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be conducted women diagnosed with Genitourinary Syndrome of Menopause treated with kinesiotherapy, divided in two groups: LED treatment or LED Sham.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LED group<br>Participants who will submitted to active procedure with LED. Both groups will be submitted to kinesiotherapy. | Procedure: Experimental: LED group<br>* 5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.<br>|
| Sham Comparator: Control group<br>Participants who will submitted to sham procedure with heated gel. Both groups will be submitted to kinesiotherapy. | Procedure: Sham Comparator: Control<br>* 5 Sessions of 8 minute with device off and heated gel, 7 days apart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal maturation index | Cytological vaginal will be collected at 1/3 lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index | Change from baseline at 3 months | 
| Female Sexual Function Index (FSFI) - Female Version (QS-F) | Measure of quality of sex life. Full Scale Score Range 2-36 | Change from baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal pH | pH indicator tape | Change from baseline at 3 months | 
| Quality of life by FACT B | Functional Assessment of Chronic Therapy- Breast (FACT B) Questionary validated to Portuguese to measure quality of life in breast cancer patients (Total score and Subscale). Graduated 0-128 (lower values means worse quality of life). Physical Wellbeing (PWB) 0-28; Social/Family Wellbeing (SWB) 0-28; Emotional Wellbeing (EWB) 0-24; Funtional Wellbeing (FWB) 0-28; Breast Cancer Subscale (BCS) 0-40. Total Score do not include Arm Subscale (ARM) 0-20 | Change from baseline at 3 months | 
| Urinary symptoms | International Consultation on Incontinence Questionnaire - Short Form (ICIQ Questionary Short Form)-Scoring scale: 0-21 (lower values means better quality of life) | Change from baseline at 3 months | 
| Visual analog scale | Stratification between 0 and 10 (few symptoms to severe symptoms) | Change from baseline at 3 months | 
| Female Genital Self-Image Scale - 7 (FGSIS-7) | Measure of quality of sex life. Scores between 7-28 (higher scores indicate better self-image) | Change from baseline at 3 months | 
| Likert scale | Satisfaction with the treatment measured between 1 and 5 ( not at all happy with the treatment -very happy with the treatment) | Change from finished treatment and 3 months after | 
| Sexual Quotients Female Version (QS-F) | Female sex life domain. Scores between 0-100 (higher scores indicate better sex life) Scores between 82-100 score: excellent, 62-80 score: regular, 42-60 score: unfavorable, 22-40 score: regular, 0-20 score: bad | Change from baseline at 3 months | 
| SF-36 | Short Form health survey 36 questionnaire, (0-100) - lower values means worse quality of life | Change from baseline at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal Atrophy, Breast Cancer, Hormonal Therapy, Photodynamic Therapy, Light Emitting Diode