--- title: "Phase III trial protocol: Vaginal radiofrequency plus moisturiser vs moisturiser alone for vulvova" id: "bmj-open-10-french-multicentre-randomised-phase-iii-trial-evaluating-the-efficacy-and" canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-10-french-multicentre-randomised-phase-iii-trial-evaluating-the-efficacy-and" content_type: "clinical_feed_article" specialty: "Oncology" source_name: "BMJ Open" source_url: "http://bmjopen.bmj.com/cgi/content/short/16/8/e118437?rss=1" published_at: "2026-08-28T09:38:04.000Z" evidence_level: "Journal Feed" license: "CC-BY-NC-4.0 / Informational Use" --- # Phase III trial protocol: Vaginal radiofrequency plus moisturiser vs moisturiser alone for vulvova ## Provenance & Clinical Metadata - **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-10-french-multicentre-randomised-phase-iii-trial-evaluating-the-efficacy-and - **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md) - **Primary Source:** BMJ Open - **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/8/e118437?rss=1) - **Published At:** 2026-08-28T09:38:04.000Z - **Evidence Rating:** Journal Feed ## Executive GIST (TL;DR) - Vulvovaginal atrophy and associated **vaginal dryness** affect up to 73% of patients treated for breast cancer due to treatment-related oestrogen deprivation of the genital tract. These symptoms are underdiagnosed and undertreated and can reduce quality of life and prompt premature discontinuation of adjuvant hormone therapy. - First-line management in this population is **non-hormonal local moisturising therapy** (hyaluronic acid–based), but this approach is often insufficient. Systemic menopausal hormone therapy is not indicated and local oestrogen is not considered first-line in patients with breast cancer. - Vaginal **radiofrequency (RF)** is proposed as a therapeutic alternative; RF stimulates fibroblasts and increases collagen synthesis, which could improve symptoms, but evidence is limited. - The RF-Vaginale trial is a multicentre, randomised phase III study comparing reference moisturising treatment alone versus moisturising treatment combined with vaginal RF (device: MATMATECH, GynWave 360). - The RF intervention comprises three sessions spaced 4–6 weeks apart. The reference treatment is a hyaluronic acid–based local moisturiser applied three times weekly. - Primary outcome: patient-rated **vaginal dryness** at 6 months on a 0–10 numerical scale; analysis will assess mean difference between arms adjusted for baseline score and patient age. - Key secondary outcomes: **dyspareunia** (0–10 patient-rated scale, assessed for patients reporting penetrative sex with a male partner) and the **Vaginal Health Index Score (VHIS)** assessed by a physician blinded to group assignment. Outcomes will also be measured at 3 and 12 months. - The trial targets patients receiving adjuvant aromatase inhibitor therapy ± luteinising hormone‑releasing hormone (LHRH) agonist. Further details such as sample size and other statistical parameters were not reported in the source. - Ethical approval was obtained from CPP Sud Est I on 12 November 2024; the protocol follows the Declaration of Helsinki and ICH E6 Good Clinical Practice guidance. Trial registration: NCT06900374. - Investigators plan international oncology congress presentations and peer‑reviewed publication of results, even if inconclusive. ## Clinical Analysis & Structured Key Points Introduction Symptoms associated with vulvovaginal atrophy affect up to 73% of patients with breast cancer, whether menopausal or non-menopausal, because certain breast cancer treatments are responsible for oestrogen deprivation on the genital tract. These symptoms are currently underdiagnosed and undertreated but can significantly impair the quality of life and can be a cause of premature discontinuation of adjuvant hormone therapy. Treatment of vulvovaginal atrophy in patients managed for breast cancer should be the first-line treatment with non-hormonal local moisturising therapy. However, this treatment is often insufficient. Systemic menopause hormone treatment is not indicated and local oestrogen treatment is not a first-line treatment in this neoplastic context. Therapeutic alternatives, such as vaginal radiofrequency (RF) treatment, could be considered. Vaginal RF increases collagen synthesis by stimulating fibroblasts. However, the vaginal RF has not been sufficiently evaluated in the literature. We hypothesised that vaginal RF can improve a patient's experience of vaginal dryness after breast cancer treatment when first-line local moisturising treatment is insufficient. Methods and analysis The RF-Vaginale trial will be a multicentre randomised phase III trial in two parallel groups until the 6-month assessment comparing a reference treatment with local moisturising (hyaluronic acid-based treatment, three times a week) versus the experimental treatment combining reference treatment+vaginal RF treatment. The vaginal RF treatment will consist of three sessions spaced 4 - 6 weeks apart (MATMATECH, GynWave 360). The primary outcome will be vaginal dryness, assessed at 6 months using a patient-rated 0 - 10 numerical scale. The secondary outcomes will be dyspareunia and Vaginal Health Index Score (VHIS). Dyspareunia will be assessed by the patient using a patient-rated 0 - 10 numerical scale, in patients reporting a sexual life with a male partner engaged in vaginal intercourse. The VHIS will be assessed by a physician blinded to the treatment group. All outcomes will also be evaluated at 3 and 12 months. This trial will be proposed to a population receiving an adjuvant treatment for breast cancer with an aromatase inhibitor ±luteinising hormone-releasing hormone (LHRH) agonist. The primary analysis will focus on the evaluation of the mean difference in vaginal dryness score at 6 months between arms, adjusted for baseline value, patient age ( Ethics and dissemination The study protocol has been approved by the ethics committee (CPP Sud Est I, 12 November 2024), complied with the Declaration of Helsinki and French laws and regulations, and followed the International Conference on Harmonisation E6 Guideline for Good Clinical Practice (reference number EMA/CHMP/ICH/135/1995). The trial results, even if inconclusive, will be presented at international oncology congresses and published in peer-reviewed journals. Trial registration number NCT06900374 . ## Related Clinical Research - [NECTIN2 promotes migration and invasion in MDA-MB-231 TNBC via LIMK1-linked cytoskeletal remodeling](https://medichelpline.com/clinical-feed/pubmed-42664293.md) (DOI: 10.1371/journal.pone.0356726) - [Chemotherapy-related fatigue in breast cancer at high altitude: mechanisms and management](https://medichelpline.com/clinical-feed/pubmed-42661012.md) (DOI: 10.1007/s00520-026-11151-6) - [On-treatment core needle biopsy predicts axillary pCR to guide axillary surgery de-escalation](https://medichelpline.com/clinical-feed/british-journal-of-cancer-0-on-treatment-core-needle-biopsy-identifies-early-responders-for-axillary.md) - [Genetic Diagnosis in Triple-Negative Breast Cancer via Exome-Based Testing](https://medichelpline.com/clinical-feed/plos-one-13-exome-based-cancer-driver-gene-comprehensive-testing-can-provide-a-genetic.md) - [Global cancer statistics 2024: epidemiological trends and healthcare priorities](https://medichelpline.com/clinical-feed/nature-reviews-clinical-oncology-0-global-cancer-statistics-2024-translating-epidemiological-trends-into.md) ## Navigation - [← Back to Oncology Feed](https://medichelpline.com/clinical-feed/oncology.md) - [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md) ## Medical & Regulatory Disclaimer > [!CAUTION] > MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations. > Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.