Light Emitting Diode for the Treatment of Genitourinary Syndrome of Menopause Associated With Hormonal Therapy for Treating Breast Cancer: Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Female Sexual Function Index (FSFI) - Female Version (QS-F)
Study Overview
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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
The participant will be randomly divided between LED group or LED Sham procedure that will consist of turned off device and heated gel and both patients and physiotherapists of kinesiotherapy phase wont be aware with group the participant is allocated.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Female Sexual Function Index (FSFI) - Female Version (QS-F)
Time Frame: Change from baseline at 3 months
Measure of quality of sex life. Full Scale Score Range 2-36
Vaginal maturation index
Time Frame: Change from baseline at 3 months
Cytological vaginal will be collected at 1/3 lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index
Secondary Outcomes
- Vaginal pH(Change from baseline at 3 months)
- Female Genital Self-Image Scale - 7 (FGSIS-7)(Change from baseline at 3 months)
- Visual analog scale(Change from baseline at 3 months)
- Quality of life by FACT B(Change from baseline at 3 months)
- Urinary symptoms(Change from baseline at 3 months)
- SF-36(Change from baseline at 3 months)
- Likert scale(Change from finished treatment and 3 months after)
- Sexual Quotients Female Version (QS-F)(Change from baseline at 3 months)