Atrophy;Vaginal, Breast Cancer
Conditions
Keywords
Vaginal Atrophy, Breast Cancer, Hormonal Therapy, Photodynamic Therapy, Light Emitting Diode
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). At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction
Interventions
PROCEDUREExperimental: LED group
5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.
PROCEDURESham Comparator: Control
5 Sessions of 8 minute with device off and heated gel, 7 days apart.
Sponsors
Centro de Atenção ao Assoalho Pélvico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal maturation index | 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 |
| Female Sexual Function Index (FSFI) - Female Version (QS-F) | Change from baseline at 3 months | Measure of quality of sex life. Full Scale Score Range 2-36 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary symptoms | Change from baseline at 3 months | International Consultation on Incontinence Questionnaire - Short Form (ICIQ Questionary Short Form)-Scoring scale: 0-21 (lower values means better quality of life) |
| Visual analog scale | Change from baseline at 3 months | Stratification between 0 and 10 (few symptoms to severe symptoms) |
| Female Genital Self-Image Scale - 7 (FGSIS-7) | Change from baseline at 3 months | Measure of quality of sex life. Scores between 7-28 (higher scores indicate better self-image) |
| Vaginal pH | Change from baseline at 3 months | pH indicator tape |
| Sexual Quotients Female Version (QS-F) | Change from baseline at 3 months | 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 |
| SF-36 | Change from baseline at 3 months | Short Form health survey 36 questionnaire, (0-100) - lower values means worse quality of life |
| Likert scale | Change from finished treatment and 3 months after | Satisfaction with the treatment measured between 1 and 5 ( not at all happy with the treatment -very happy with the treatment) |
| Quality of life by FACT B | Change from baseline at 3 months | 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 |
Countries
Brazil
Outcome results
None listed