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NCT Number: NCT06900374

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

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.

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Key information

Conditions

Vaginal Dryness Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Vulvovaginal Atrophy

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.).

Primary outcomes

  1. Numerical scale for vaginal dryness according to patient

    Time frame: 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).

    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.

Secondary outcomes

  1. Patient-Rated 0-10 numerical scale for dyspareunia

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

    Patient-rated 0-10 numerical rating scale for dyspareunia, minimum value = 0; maximum value = 10; where 0 = No pain during intercourse and 10 = Maximum possible pain

  2. Vaginal Health Index Score (VHIS) : vaginal elasticity score

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

    Vaginal elasticity is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:

    • = None
    • = Poor
    • = Fair
    • = Good
    • = Excellent

    Higher scores indicate better vaginal elasticity.

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

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

    Vaginal fluid volume is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:

    • = None
    • = Scar amount (vault not entirely covered)
    • = Superficial amount (vault entirely covered)
    • = Moderate amount
    • = Normal amount Higher scores indicate greater fluid volume, which reflects better vaginal hydration.

  4. Vaginal Health Index Score (VHIS) : vaginal pH measurement

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

    Vaginal pH is measured using a pH test strip applied to the vaginal mucosa by a physician observer. The pH is categorized as follows:

    • = ≥6.1
    • = 5.6-6.0
    • = 5.1-5.5
    • = 4.7-5.0
    • = ≤4.6 Lower values indicate a healthier vaginal environment.

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

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

    Epithelial integrity is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:

    • = Petechiae noted before contact
    • = Bleeds with light contact
    • = Bleeds with scraping
    • = Not friable (thin epithelium)
    • = Normal Higher scores indicate better vaginal epithelial integrity.

  6. Vaginal Health Index Score (VHIS): vaginal moisture score

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

    Vaginal moisture is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:

    • = None (surface inflamed)
    • = None (surface non-inflamed)
    • = Minimal
    • = Moderate
    • = Normal Higher scores indicate better vaginal moisture levels.

  7. Side effects of radiofrequency treatment

    Time frame: through study completion: 12 months

    Type of side effects : sensation of heat, redness, erythema, hypersensitivity, dyspareunia, other.

    Time of onset : during the session, immediately after, or more than 24 hours after the session.

    Intensity : graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0), with scores ranging from Grade 1 (mild) to Grade 5 (death). Higher scores indicate greater severity of adverse effects.

    Consequences for the treatment: need to interrupt the session, reduce the radiofrequency temperature, etc.

Other outcomes

  1. Occurrence of discontinuation or modification of hormone therapy

    Time frame: through study completion: 12 months

    • At each follow-up visit 3 months, 6 months, 12 months post-randomization : data collection on any discontinuation of initially prescribed hormone therapy, change of hormone therapy, other changes in treatment, and reasons for these changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Fanny BEN OUNE

CONTACT

[email protected]

+33320295896

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • MATMATECH

Registry information

Official study 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

Acronym: RF-Vaginale

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 28, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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