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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
77
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.
Centro de Atenção ao Assoalho Pelvico
Salvador, Estado de Bahia, Brazil
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
Time frame: 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
Time frame: Change from baseline at 3 months
Vaginal pH
pH indicator tape
Time frame: 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
Time frame: 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)
Time frame: Change from baseline at 3 months
Visual analog scale
Stratification between 0 and 10 (few symptoms to severe symptoms)
Time frame: Change from baseline at 3 months
Female Genital Self-Image Scale - 7 (FGSIS-7)
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Measure of quality of sex life. Scores between 7-28 (higher scores indicate better self-image)
Time frame: 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)
Time frame: 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
Time frame: Change from baseline at 3 months
SF-36
Short Form health survey 36 questionnaire, (0-100) - lower values means worse quality of life
Time frame: Change from baseline at 3 months