Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment
Condition: Atrophy;Vaginal; Breast Cancer
MeSH terms: Breast Neoplasms; Atrophy
Study type: Interventional

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

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 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
    

Intervention name(s): Experimental: LED group; Sham Comparator: Control
Intervention type(s): Procedure; Procedure
Intervention description(s): 5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.; 5 Sessions of 8 minute with device off and heated gel, 7 days apart.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Vaginal Atrophy; Breast Cancer; Hormonal Therapy; Photodynamic Therapy; Light Emitting Diode