Clinical trial NCT06900374: Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaginal Dryness
Breast Cancer
Vulvovaginal Atrophy
Keywords: Vaginal dryness
vaginal atrophy
vaginal radiofrequency
breast cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: MATMATECH
First posted: 2025-03-28
Enrollment: 75
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The evaluator will be blinded to the intervention (different investigator for vaginal radiofrequency sessions and clinical evaluation consultations) Blinding will be lifted after the 6-month evaluation, with the possibility of radiofrequency treatment for control group patients who are insufficiently relieved
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study aims to see if vaginal radiofrequency therapy can help reduce vaginal dryness in women receiving hormone therapy for breast cancer.

The participants are divided into two groups:

One group will use a non-hormonal vaginal moisturizer (hyaluronic acid) three times a week. If needed, they can also use other supportive treatments like physiotherapy or vaginal dilators.

The other group will receive the same moisturizer treatment but will also have three sessions of vaginal radiofrequency therapy, with each session spaced 4 to 6 weeks apart.

After six months, researchers will compare the two groups to see if vaginal radiofrequency provides additional benefits in relieving vaginal dryness.

Eligibility 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.

Primary outcomes:
measure: Numerical scale for vaginal dryness according to patient
timeFrame: The main analysis will focus on assessment at 6 months (M6). This endpoint will also be assessed at baseline (M0), 3 and 12 months (M3, M12).
Secondary outcomes:
measure: Patient-Rated 0-10 numerical scale for dyspareunia
timeFrame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
measure: Vaginal Health Index Score (VHIS) : vaginal elasticity score
timeFrame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
measure: Vaginal Health Index Score (VHIS) : vaginal fluid volume score
timeFrame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
measure: Vaginal Health Index Score (VHIS) : vaginal pH measurement
timeFrame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
measure: Vaginal Health Index Score (VHIS): vaginal epithelial integrity score
timeFrame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
measure: Vaginal Health Index Score (VHIS): vaginal moisture score
timeFrame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)
measure: Side effects of radiofrequency treatment
timeFrame: through study completion: 12 months
Other outcomes:
measure: Occurrence of discontinuation or modification of hormone therapy
timeFrame: through study completion: 12 months
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Julie DEMETZ, MD
role: STUDY_DIRECTOR
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