Vaginal radiofrequency for vulvovaginal atrophy in people with breast cancer
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
This will see if adding three sessions of vaginal radiofrequency to regular hyaluronic acid moisturizer reduces vaginal dryness in women taking aromatase inhibitors for breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Centre Oscar Lambret Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT06900374 on ClinicalTrials.gov |
What this trial studies
This is a randomized, parallel-group Phase III trial comparing standard non-hormonal vaginal hydration with the same hydration plus three sessions of vaginal radiofrequency given 4–6 weeks apart. Eligible participants are women over 40 receiving adjuvant aromatase inhibitor therapy (with or without LHRH agonists) who have persistent, significant vaginal dryness despite moisturizers. The primary comparison measures symptoms of vaginal dryness at six months after randomization. Supportive measures such as physiotherapy or vaginal dilators may be allowed alongside the moisturizer in both groups.
Who should consider this trial
Good fit: Women over 40 on adjuvant aromatase inhibitor therapy (with or without LHRH agonists) who have persistent, bothersome vaginal dryness despite regular non-hormonal moisturization are the ideal candidates.
Not a fit: Patients with contraindications to radiofrequency (active UTI, pacemaker, intrauterine device, pregnancy), active vulvovaginal mucocutaneous disease, recent vaginal energy or injectable procedures, or neurodegenerative perineal involvement are unlikely to benefit or cannot participate.
Why it matters
Potential benefit: If successful, adding vaginal radiofrequency could provide greater relief from vaginal dryness and improve sexual comfort and quality of life for women who cannot use hormonal treatments.
How similar studies have performed: Small uncontrolled and short-term studies of vaginal radiofrequency and other energy-based devices have reported symptom improvements in genitourinary syndrome of menopause, but high-quality randomized evidence—especially in breast cancer patients—is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA : * Patient over 40 years * Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3 * Patient undergoing adjuvant treatment for breast cancer * Patient treated with aromatase inhibitors +/- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months * Patient affiliated to a social security organization * Patient having signed the informed consent for the present study EXCLUSION CRITERIA: * Contraindications related to the radiofrequency technique: * Ongoing urinary tract infection * Pacemaker * IUD intrauterine device * Pregnancy * Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc. * Neurodegenerative disease with perineal involvement * Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling. * Pregnant or breast-feeding women * Patients under guardianship or trusteeship.
Where this trial is running
Lille
- Centre Oscar Lambret — Lille, France (Recruiting)
Study contacts
- Study coordinator: Fanny BEN OUNE
- Email: promotion@o-lambret.fr
- Phone: +33320295896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.