Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

NCT06900374 | Recruiting

• 3 other identifiers: RF-Vaginale-2401API-23-182024-A01126-41
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Dryness; Breast Cancer; Vulvovaginal Atrophy

Keywords

Vaginal dryness; vaginal atrophy; vaginal radiofrequency; breast cancer

Outcome Measures

Primary Outcomes (1)

• Numerical scale for vaginal dryness according to patient

  Patient-rated 0-10 Numerical Rating Scale for vaginal dryness, minimum value =0; maximum value = 10; where 0 = No dryness and 10 = Maximum possible dryness.

  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 (7)

• Patient-Rated 0-10 numerical scale for dyspareunia

  baseline (M0), 3, 6 and 12 months (M3, M6, M12)

• Vaginal Health Index Score (VHIS) : vaginal elasticity score

  baseline (M0), 3, 6 and 12 months (M3, M6, M12)

• Vaginal Health Index Score (VHIS) : vaginal fluid volume score

  baseline (M0), 3, 6 and 12 months (M3, M6, M12)

• Vaginal Health Index Score (VHIS) : vaginal pH measurement

  baseline (M0), 3, 6 and 12 months (M3, M6, M12)

• Vaginal Health Index Score (VHIS): vaginal epithelial integrity score

  baseline (M0), 3, 6 and 12 months (M3, M6, M12)

Other Outcomes (1)

• Occurrence of discontinuation or modification of hormone therapy

  through study completion: 12 months

Study Arms (2)

Vaginal radiofrequency treatment

EXPERIMENTAL

The evaluator will be blinded to the intervention (different investigator for vaginal radiofrequency sessions and clinical evaluation consultationsup to 6 months, M0, M3 and M6). The blinding will be lifted after the 6-month evaluation, with the possibility of radiofrequency treatment for patients in the control group who are not sufficiently relieved.

Device: GynWave-360; Other: Local hydratation

Reference treatment

ACTIVE COMPARATOR

Local hydration: hyaluronic acid-based treatment, 3 applications per week Possibility of resorting to associated measures chosen by the investigator (physical therapy, vaginal dilators, etc.), excluding physical treatments (vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection, or lipomodelling).

Other: Local hydratation

Interventions

GynWave-360 DEVICE

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).

Vaginal radiofrequency treatment

Local hydratation OTHER

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.).

Reference treatment; Vaginal radiofrequency treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• MATMATECH: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Julie DEMETZ, MD

  Centre Oscar Lambret

  STUDY DIRECTOR

Central Study Contacts

Fanny BEN OUNE

CONTACT

+33320295896; promotion@o-lambret.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 28, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)