protocolSection identificationModule nctId: NCT06347926, orgStudyIdInfo id: PROICM 2023-11 EVA, briefTitle: Evaluation of the Effect of Photobiomodulation on Sexual Quality of Life in Women With Breast Cancer, acronym: EVABIOSEIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Institut du Cancer de Montpellier - Val d'Aurelle, class: OTHER, descriptionModule briefSummary: The treatment of breast cancer as well as the disease are responsible for genito-urinary symptoms that can persist over time and impair quality of life. Given the improved prognosis of breast cancer, more and more patients are confronted with specific post-cancer issues, and the care has become a major health challenge.Sexual health is a crucial component of well-being and overall quality of life. Vaginal dryness and dyspareunia are symptoms frequently found in patients treated for breast cancer, with chemotherapy and hormone therapy as risk factors. However, the treatment of sexual disorders remains underdeveloped in France.Vaginal dryness is part of a broader syndrome known as genitourinary syndrome of menopause (GSM), or vulvovaginal atrophy, which may combine vulvovaginal (dryness, irritation, burning), sexual (dyspareunia) and urinary (infections, pollakiuria, urgency) symptoms secondary to hypoestrogenemia, exacerbated by breast cancer treatments. Since hormonal treatments are contraindicated, the first-line treatment for GSM in patients treated for breast cancer is the application of non-hormonal trophic treatments (regular vaginal moisturizers, lubricants during intercourse). However, these treatments are often insufficient to provide effective relief. There is therefore growing interest in the development of second-line treatments for GSM : intra-vaginal hyaluronic acid injections, laser, photobiomodulation (PBM), etc. PBM using Light Emitting Diodes (LED) has been proposed as an alternative treatment for genitourinary syndrome of the menopause. The tissues are exposed to light sources in the visible spectrum, inducing non-thermal, non-cytotoxic biological effects that improve vaginal tissue trophicity. A study is planned to evaluate the use of photobiomodulation in 2nd-line treatment of GSM (after 1st-line treatment with vaginal moisturizers) and on the quality of sexual life of patients treated for breast cancer at any stage of treatment., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Treatment by photobiomodulation, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Photobiomodulation, outcomesModule primaryOutcomes measure: Sexual satisfaction score on one dimension of the SHQ-22 questionnaire, secondaryOutcomes measure: Sexual quality of life scores obtained on all dimensions of the SHQ-22 questionnaire, secondaryOutcomes measure: Patient Global Impression of Improvement (PGI-I) score, secondaryOutcomes measure: Determination of the Vaginal Health Index clinical score, secondaryOutcomes measure: Determination of symptoms of vulvovaginal atrophy by a visual numerical scale, secondaryOutcomes measure: Determination of adverse events by using Common Terminology Criteria for Adverse Events (CTCAE) scale of the National Cancer Institute., secondaryOutcomes measure: Number of patients taking other treatments for treating sexual troubles, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Cancer in Montpellier, city: Montpellier, state: Hérault, zip: 34298, country: France, contacts name: Angélique Bobrie, MD, role: CONTACT, phone: 467618576, phoneExt: +33, email: angelique.bobrie@icm.unicancer.fr, contacts name: Angélique Bobrie, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, hasResults: False