[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvovaginal-atrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvovaginal-atrophy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100636279","determining-the-extent-of-the-genitourinary-syndrome-of-menopause-burden-in-breast-cancer-survivors-100636279",false,"NCT07563621","Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors","Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study","V-light cohort","Inclusion Criteria:\n\n* Women diagnosed with breast cancer stage 0, I, II, and III\n* Prior to CT\u002FET, receiving only one of both (no combination)\n* Age 18 years or above\n* Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)\n* Dutch-speaking (be able to understand the informed consent and study-related questionnaires)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Concomitant CT and ET treatment\n* Structural restorative therapies, such as photobiomodulation therapy (PBM) and fractional CO₂ laser treatment, are not permitted during the study period. During the study period, only symptomatic treatment of GSM (e.g., vaginal lubricants or moisturizers) will be allowed",true,"FEMALE","18 Years",{"count":21,"type":22},264,"ESTIMATED","12 Months","OBSERVATIONAL","Breast cancer survivors (BCS) often face unique challenges during and after treatment, including the onset of menopause-related symptoms. Genitourinary Syndrome of Menopause (GSM) is a common concern in BCS undergoing endocrine therapy (ET). It is a chronic condition caused by estrogen deficiency, leading to vaginal and urinary symptoms such as dryness, irritation, pain during intercourse, recurrent infections, and urinary urgency.\n\nThe prevalence of GSM in BCS varies widely depending on factors such as the type of ET, individual patient characteristics, and the duration of treatment. As such, the prevalence of GSM in BCS can range from 13% to 95.2%. A recent systematic review performed by part of the investigators of this study concludes that GSM is a significant problem for breast cancer patients. However, most studies lack a control group, limiting the results' validity. Therefore, this study aims to determine the extent of the GSM burden in BCS using a prospective, controlled cohort study. This study will compare breast cancer patients receiving endocrine therapy (ET) with those undergoing chemotherapy (CT), as CT may also induce GSM-like symptoms. In addition, a comparison will be made with healthy controls.\n\nFor this study, two groups of participants are included: women with breast cancer and a healthy control group without breast cancer. Within the breast cancer group, a distinction is made between women receiving chemotherapy only and women undergoing hormone therapy only. All participants complete questionnaires. The control group completes these questionnaires once, whereas women with breast cancer are asked to complete the same questionnaires at multiple time points during their treatment and follow-up. This longitudinal approach allows us to assess how potential symptoms evolve over the course of treatment. By comparing responses between both groups, a clearer understanding of which symptoms occur more frequently in women with breast cancer as a consequence of their treatment can be obtained.",[27,28,29,30],"Genitourinary Syndrome of Menopause (GSM)","Breast Cancer","Vulvovaginal Atrophy","Genitourinary Syndrome of Menopause","RECRUITING","2026-04-29",{"date":34,"type":35},"2026-05-04","ACTUAL",{"date":37,"type":35},"2026-03-05",{"date":39,"type":22},"2028-08-31",{"name":41,"class":42},"Jessa Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100585285","efficacy-and-safety-of-vaginal-radiofrequency-for-vulvovaginal-atrophy-in-breast-cancer-patients-100585285","NCT06900374","Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients","RF-Vaginale : Randomised Phase III Trial Evaluating the Efficacy and Safety of Vaginal Radiofrequency in the Management of Vulvovaginal Atrophy and Dryness in Patients Treated for Breast Cancer","RF-Vaginale","INCLUSION CRITERIA :\n\n* Patient over 40 years\n* Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3\n* Patient undergoing adjuvant treatment for breast cancer\n* Patient treated with aromatase inhibitors +\u002F- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months\n* Patient affiliated to a social security organization\n* Patient having signed the informed consent for the present study\n\nEXCLUSION CRITERIA:\n\n* Contraindications related to the radiofrequency technique:\n\n  * Ongoing urinary tract infection\n  * Pacemaker\n  * IUD intrauterine device\n  * Pregnancy\n* Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc.\n* Neurodegenerative disease with perineal involvement\n* Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling.\n* Pregnant or breast-feeding women\n* Patients under guardianship or trusteeship.","40 Years",{"count":54,"type":22},75,"INTERVENTIONAL",[57],"NA","This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer.\n\nPatients will be randomly assigned to one of two parallel treatment groups until the six-month assessment:\n\nThe first group will receive the reference treatment, which consists of local hydration using a hyaluronic acid-based treatment applied three times a week. Additionally, investigators may incorporate supportive measures at their discretion, such as physiotherapy or vaginal dilators.\n\nThe second group will receive the same reference treatment combined with vaginal radiofrequency therapy. This intervention consists of three sessions, each spaced 4 to 6 weeks apart.",[60,28,29],"Vaginal Dryness",[62,63,64,65],"Vaginal dryness","vaginal atrophy","vaginal radiofrequency","breast cancer","2026-03-16",{"date":68,"type":35},"2026-03-18",{"date":70,"type":35},"2025-06-12",{"date":72,"type":22},"2028-06",{"name":74,"class":42},"Centre Oscar Lambret"]