Light emitting diode for the treatment of genitourinary syndrome of menopause in breast cancer survivors: study protocol for a double blinded trial
Keywords:Breast neoplasms, GSM, LED, Photobiomodulation, Therapy
Background: Genitourinary Syndrome of Menopause (GSM) after breast cancer are secondary to many mechanisms such long-term side effects of cancer treatment. Light-Emitting Diode (LED) is a treatment aimed at improving vaginal epithelial tissue. This study will aim to analyze the effects of 405 nm LED on GSM of breast cancer survivors.
Methods: This double-blind, randomized clinical trial will be conducted with breast cancer survivors aged 18-65 years, diagnosed with GSM, with at least one sign and one symptom of GSM and vaginal pH≥5 or proven cytologic hypotrophy or atrophy. Pregnant women, those who received hormone replacement within the prior 6 months, with active vaginal infection, impaired comprehension, neurological disease, and progression to metastatic disease during the protocol, will be excluded. LED will be applied intravaginally with gel heated to 38ºC. Each 5/weekly session will last 8 minutes, concurrent with pelvic floor muscle kinesiotherapy. The control group will be treated with the same protocol with LED device turned off. Response will be assessed with the Vaginal Maturation Index analysis, vaginal cytology, and questionnaires to evaluate urinary complains, sexual function, genital self-image and quality of life. Satisfaction will be assessed using a Visual Analog and Likert scale. Measurements will be performed pre-treatment, post-treatment week-3, and month-2 and 3.
Conclusions: We aim to identify the benefits of LED for breast cancer survivors with GSM.
Trial registration: Clinical trials registration number NCT03833726-version 2.0, July 28, 2019.
Portman DJ, Gass MLS. 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. J Sex Med. 2014;11:2865-72.
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;17(3):252- 9.
Moreno AC, Sikka SK, Thacker HL. Genitourinary syndrome of menopause in breast cancer survivors: Treatments are available. Cleve Clin J Med. 2018;85(10):760-6.
Lester J, Pahouja G, Andersen B, Lustberg M. Atrophic vaginitis in breast cancer survivors: a difficult survivorship issue. J Pers Med. 2015;5(2):50-66.
Lanzafame RJ, De la Torre S, Leibaschoff GH. The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes. Photobiomodulation, Photomedicine Laser Surg. 2019;37(7):395-407.
Sussman TA, Kruse ML, Thacker HL, Abraham J. Managing Genitourinary Syndrome of Menopause in Breast Cancer Survivors Receiving Endocrine Therapy. J Oncol Pract 2019;15(7):363-70.
Opel DR, Hagstrom E, Pace AK, Sisto K, Hirano-Ali SA, Desai S et al. Light-emitting diodes: a brief review and clinical experience. J Clin Aesthet Dermatol. 2015;8(6):36-44.
Arroyo C. Fractional CO2 laser treatment for vulvovaginal atrophy symptoms and vaginal rejuvenation in perimenopausal women. Int J Women’s Health. 2017;9:591-5.
García PN, Elias JA, Parada JG, Luciañez DZ. Management of Vaginal Atrophy with Intravaginal Light-Emitting Diodes (LEDs). Pint H Int J Obst Gynaecolo Res. 2018;5(2):632-41.
Pavie MC, Robatto M, Bastos M, Tozetto S, Vilas-Boas A, Vitale SG, Lordelo P. Blue light-emitting diode in healthy vaginal mucosa-a new therapeutic possibility. Lasers Med Sci. 2019;34(5):921-7.
Robatto M, Pavie MC, Tozetto S, Brito MB, Lordêlo P. Blue light emitting diode in treatment of recurring vulvovaginal candidiasis: a case report. Brazilian J Med Human Health. 2017;5(4):162-8.
Nilsson K, Risbergb B, Heimerc G. The Vaginal Epithelium in the Postmenopause: Cytology, Histology and Ph as Methods of Assessment. Maturitas. 1995;5122(94):51-6.
American Joint Committee on Cancer. AJCC Cancer Staging Manual-8th. Chicago-Il. Springer. 2017;983.
Hentschel H, Alberton DL, Capp E, Goldim JR, Passos EP. Validação Do Female Sexual Function Index (FSFI) Para Uso Em Língua Portuguesa Revista HCPA. 2007;27(1):10-4.
Helena C, Abdo N. Quociente sexual feminino: um questionário brasileiro para avaliar a atividade sexual da mulher. Medibina Sex. 2009;14(2):89-91.
Herbenick D, Reece M. Development and validation of the female genital self-image scale. J Sex Med. 2010;7(5):1822-30.
Tamanini JTN, Dambros M, D’Ancona CAL, Palma PCR, Rodrigues Netto NJr. Validação para o português do “International Consultation on Incontinence Questionnaire-Short Form” (ICIQ-SF). Rev Saúde Pública. 2004;38(3):438-44.
Michels FAZ, Latorre MRDO, Maciel MS. Validação e reprodutibilidade do questionário FACTB+4 de qualidade de vida específico para câncer de mama e comparação dos questionários IBCSG, EORTC-BR23 e FACT-B+4. Cad Saúde Colet. 2012;20(3):321-8.
Ciconelli RM, Ferraz MB, Santos W, Meinão I, Quaresma MR. Tradução e validação do SF36. Rev Bras Reumatol. 1999;39(3):143-50.
Bachmann G. Urogenital ageing: an old problem newly recognized. Maturitas. 1995;22:S1-5.
U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) 2017;5.0.
Laycock J, Jerwood D. Pelvic Floor Muscle Assessment: The PERFECT Scheme. Physiotherapy. 2001;87(12):631-42.
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;84:75-80.