RecruitingNot ApplicableNCT06900374

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

Sponsor

Centre Oscar Lambret

Enrollment

75 participants

Start Date

Jun 15, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Vaginal Dryness Vulvovaginal Atrophy

Summary

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. Patients will be randomly assigned to one of two parallel treatment groups until the six-month assessment: The 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. The 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.

Eligibility

Sex: FEMALEMin Age: 40 Years

Inclusion Criteria6

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 Criteria10

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.

Interventions

DEVICEGynWave-360

For patients randomized to the experimental group: 3 sessions of 20 minutes each, spaced 4 to 6 weeks apart (M0, M1, M2) ideally, with +/- 1 maintenance session between 8 and 12 months after the first session (M8-12).

OTHERLocal hydratation

Reference treatment combining local hydration (hyaluronic acid-based treatment, 3 times a week), with the possibility of using associated measures at the investigator's discretion (physiotherapy, vaginal dilators, etc.).