Light emitting diode for the treatment of genitourinary syndrome of menopause in breast cancer survivors (LEDCA): preliminary results of a randomized double-blind clinical trial

Barros D1, Alvares C2, Brasil C2, Gomes T2, Lemos A2, Teles A2, Pires J3, Alves R2, Vieira C2, Lima A2, Marianno A1, Costa T2, Marduy A4, Passos R4, Fontes A4, Jorge D2, Araújo E2, Campos G2, Celino G2, Cerqueira M5, Ferreira R2, Torrieri C6, Lordelo P2

Research Type

Clinical

Abstract Category

Conservative Management

Abstract 562
ePoster 8
Scientific Open Discussion Session 36
On-Demand
Clinical Trial New Devices Sexual Dysfunction Quality of Life (QoL)
1. Escola Bahiana de Medicina e Saúde Pública, Centro de Atenção ao Assoalho Pélvico, Instituto Patricia Lordelo, Hospital Santa Izabel, 2. Escola Bahiana de Medicina e Saúde Pública, Centro de Atenção ao Assoalho Pélvico, Instituto Patricia Lordelo, 3. Centro Universitário Estácio do Ceará, Faculdade IDE, 4. União Metropolitana para o Desenvolvimento da Educação e Cultura - UNIME, 5. Centro de Atenção ao Assoalho Pélvico, Instituto Patricia Lordelo, 6. CT Clinical
Presenter
D

Daniela Barros

Links

Abstract

Hypothesis / aims of study
Genitourinary Syndrome of Menopause (GSM) affects up to 70% of breast cancer patients. Nowadays, the available treatments such lubricants and moisturizers do not provide a sustained relief for some of the symptoms. (1) It is known that phototherapy can provide fibroblast stimulation and increase microcirculation, thus (2) a light-emitting diode (LED) photo application appears as an alternative to improve vaginal epithelial tissue (3). We hypothesize that LED has a positive effect on cell maturation and vaginal microenvironment promoting better quality of life and improving sexual function.  We present the preliminary analysis of a co-primary endpoint of sexual function of this trial and secondary endpoint of genital image and urinary symptoms of this original study. Therefore, the aim is to analyze the effect of the 405nm LED on cell maturation, pH, sexual function, genital image and urinary symptoms in women with GSM caused by breast cancer treatment.
Study design, materials and methods
This is a randomized double-blind clinical trial, that includes women aged between 18 and 65 years with pathological proven breast cancer Stage 0-III. Exclusion criteria are pregnancy, inability of understanding the proposed evaluation instruments, progression to metastasis disease during the protocol, the presence of vaginal infection or chronic neurological degenerative diseases that preclude to be on gynecological position. For this co-primary endpoint we estimated a sample size of 58 patients for a detectable difference of 5 points on the Female Sexual Function Index (FSFI) with an SD (standard deviation) of 7.7 and 5.6 and an alpha error of 0.05 and power of 80%. Patients are randomly divided into two groups, 1:1 to either the LED or LED sham. The light spectrum and irradiation provided by the LED device developed for the study (patent application no. BR 10 2017 026980 9) (Figura 1). The intervention consists of 5 weekly sessions of 8 minutes of 405 nm blue LED, 1.66W/m2, using a hybrid device capable of covering vulvar and intravaginal treatment area. In addition, pelvic floor muscle training is performed in the same day of LED/sham treatment. To assess sexual function we applied the FSFI questionnaire and the Sexual Quotient – Female Version (QS-F). The genital self-image was evaluated by Female Genital Self-Image Scale - 7 (FGSIS-7).  Urinary symptoms were assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). All questionnaires applied were previously validated in the Portuguese language. Visual analogue scales of complains and satisfaction were also used. These assessments were done both pre and after treatment (at 3 weeks, 2 and 3 months follow-up). The patients signed the Informed Consent Form.
Results
A total of 12 women were included – 7 participants in the study group (SG) and 5 in the control group (CG), with a mean age of 49,5±7,4 and 45,6±6,1, respectively. In the SG 85% of the participants were menopaused, in comparison to 40% in the CG. The majority of the population studied are sexually active (66,7%). High scores of self-report symptoms were observed such vaginal dryness (91,7%), dyspareunia (50%), itching (50%), burning sensation (41,7%) and vaginal laxity (33,3%). About 83,8% of women were considered with a satisfactory perineal awareness (85,7% in SG and 100% in CG) and 58,3% with a satisfactory muscle coordination (71,4% in SG and 50% in CG). Regarding urinary symptoms, 57,1% of the SG presented urinary urgency, and 60% of the CG, nocturia 42.9% and 40%, urinary incontinence of 57.1% and 20%, respectively. Before treatment, the scores obtained by QS-F were 56(43-69) in the SG and 36(24-48) in the CG. During follow-up evaluation, the scores showed a significant change in the SG – 80(79-89, p=0,04). However, during de same period, the QS-F score in the CG was 64(40-69), with no significant difference (p=0.5). The FSFI and ICIQ-SF scores are shown in Table 1 – with no significant differences when comparing both groups before and after therapy. Most participants, 3(42.9%) in the SG and 2(40%) in the CG, reported feeling "very satisfied" according to the Likert Scale
Interpretation of results
Up to now, it is early to identify statistic differences. However, it is possible to observe that the FSFI scores have doubled after treatment. Meanwhile, the other two scores recorded (QS-F and ICIQ-SF) have also showed an improvement at the same follow-up period.
Concluding message
This trial shows promising benefits of a hybrid original device capable of treating a wide genital area, with the potential to bring relief of sexual and urinary symptoms for breast cancer survivors’ patients.
Figure 1
Figure 2
References
  1. 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. Review. Erratum in: Cleve Clin J Med. 2018 Nov;85(11):860. PubMed ID: 30289755
  2. Raymond J. Lanzafame; Sarah de la Torre and Gustavo H. Leibaschoff. 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, and Laser Surgery Volume 37, Number 7, 2019 Mary Ann Liebert, Inc. Pp. 395–407 DOI: 10.1089/photob.2019.4618
  3. 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 in Medical Science. 2019 Jul;34(5):921-927 https://doi.org/10.1007/s10103-018-2678-3
Disclosures
Funding No funding received Clinical Trial Yes Registration Number The Clinical Trials registration number was NCT03833726 RCT Yes Subjects Human Ethics Committee The study was approved by the Ethics Committee of the Bahiana School of Medicine and Public Health through CAAE 70078717.4.0000554 4 Helsinki Yes Informed Consent Yes
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