Light emitting diode for the treatment of genitourinary syndrome of menopause in breast cancer survivors: study protocol for a double blinded trial
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.
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