LIGHT EMITTING DIODE FOR THE TREATMENT OF GENITOURINARY SYNDROME OF MENOPAUSE IN BREAST CANCER SURVIVORS (LED-CA): STUDY PROTOCOL FOR A DOUBLE BLINDED TRIAL

Keywords:

Breast Cancer - Rehabilitation - Sexual Dysfunction

Introduction: Genitourinary Syndrome of Menopause (GSM) after breast cancer occurs associated with long-term side effects of cancer treatment. Light-Emitting Diode (LED) is an instrument potentially capable of stimulate the epithelium, and so mitigate symptoms, with low side-effects and lower cost than other energy-based devices. Objective: This study aims to analyze the effects of blue LED on GSM and its ability to regenerate the vaginal epithelium of breast cancer survivors Methods: This is double-blind, clinical trial, randomized to 1:1 conducted with breast cancer survivors, staged 0-III, aged 18-65 years, with at least one sign and symptom of GSM and vaginal pH≥5 or proven cytologic hypotrophy/atrophy. It is approved by local Research Ethics Committee and registred in ClinicalTrials.com. Exclusion criteria are pregnancy, hormone replacement less than 6 months, vaginal infection, impaired comprehension, neurological disease and progression to metastasis. The protocol consists of 5/weekly session of 8 minutes of 405nm LED or sham. Both groups are treated with pelvic muscle floor kinesiotherapy. Response are assessed with the Vaginal Maturation Index (VMI), Vaginal Health Index and vaginal pH. Urinary complains are assessed with ICIQ-SF, quality of life with FACT-B questionnaire and satisfaction with Likert scale. Evaluation are performed before and after treatment at 3-weeks, 2 and 3 months. A sample size of 74 patients were estimated, 37 in each group, inflated to 10% of loss, for a standard deviation of 8 to detect a 10-point difference in the VMI with an alpha error of 0.05 and power of 80%. Results: Until this date, 50 patients were screened and randomized and 33 completed treatment, 20 in study group and 13 in control group. The mean of age were 53(7.6±) and 50.5(7.7±), in LED and sham group, with p= 0.36. There was no differen in race, schooling or finantial status. No difference were observed on baseline mean of VMI, (34 in LED group and 23 in sham group with p= 0.25). The VHI were also similar (16.2 and 14.1 with p= 0.21). An increasing in VMI mean were observed in both groups after treatment with ANOVA of repeated measures, (p= 0.53), with the evolution of value in LED group: before=34 and after-treatment= 37, 33, 45 (3 weeks, 2 and 3 months) and in sham group, before= 24 and 35, 34,2, 49. Conclusion: Until now is not possible to demonstrate cytological differences on LED treatment. No relevant side effects wore described and the complete of accrual are expected for final analysis of this trial.

 

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Publikationsverlauf

Artikel online veröffentlicht:
17. November 2021