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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LED group | Experimental | Participants who will submitted to active procedure with LED. Both groups will be submitted to kinesiotherapy. |
|
| Control group | Sham Comparator | Participants who will submitted to sham procedure with heated gel. Both groups will be submitted to kinesiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: LED group | Procedure | 5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PatrÃca V Lordelo, PhD | Centro de Atenção Pélvica- CAAP | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Atenção ao Assoalho Pelvico | Salvador | Estado de Bahia | 40.290-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25815692 | Background | Lester J, Pahouja G, Andersen B, Lustberg M. Atrophic vaginitis in breast cancer survivors: a difficult survivorship issue. J Pers Med. 2015 Mar 25;5(2):50-66. doi: 10.3390/jpm5020050. | |
| 23805799 | Background | Kyvernitakis I, Ziller V, Hars O, Bauer M, Kalder M, Hadji P. Prevalence of menopausal symptoms and their influence on adherence in women with breast cancer. Climacteric. 2014 Jun;17(3):252-9. doi: 10.3109/13697137.2013.819327. Epub 2013 Aug 25. |
| Label | URL |
|---|---|
| NCI Toxicity Scale | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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The study will be conducted women diagnosed with Genitourinary Syndrome of Menopause treated with kinesiotherapy, divided in two groups: LED treatment or LED Sham.
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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.
| Sham Comparator: Control | Procedure | 5 Sessions of 8 minute with device off and heated gel, 7 days apart. |
|
| 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 |
| 25179577 | Background | Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Maturitas. 2014 Nov;79(3):349-54. doi: 10.1016/j.maturitas.2014.07.013. Epub 2014 Aug 19. |
| 7731384 | Background | Nilsson K, Risberg B, Heimer G. The vaginal epithelium in the postmenopause--cytology, histology and pH as methods of assessment. Maturitas. 1995 Jan;21(1):51-6. doi: 10.1016/0378-5122(94)00863-3. |
| 30289755 | Background | Moreno AC, Sikka SK, Thacker HL. Genitourinary syndrome of menopause in breast cancer survivors:Treatments are available. Cleve Clin J Med. 2018 Oct;85(10):760-766. doi: 10.3949/ccjm.85a.17108. |
| 28154914 | Background | Arunkalaivanan A, Kaur H, Onuma O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: a critical appraisal of evidence. Int Urogynecol J. 2017 May;28(5):681-685. doi: 10.1007/s00192-017-3282-y. Epub 2017 Feb 2. |
| 26617271 | Background | Yaralizadeh M, Abedi P, Najar S, Namjoyan F, Saki A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial. Maturitas. 2016 Feb;84:75-80. doi: 10.1016/j.maturitas.2015.11.005. Epub 2015 Nov 12. |
| D017437 |
| Skin and Connective Tissue Diseases |