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

Overview

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.

Interventions

• Device GynWave-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).
• Other Local 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.).

Primary outcome measures

• 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).]

Secondary outcome measures (7)

• Patient-Rated 0-10 numerical scale for dyspareunia [Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)]
• Vaginal Health Index Score (VHIS) : vaginal elasticity score [Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)]
• Vaginal Health Index Score (VHIS) : vaginal fluid volume score [Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)]
• Vaginal Health Index Score (VHIS) : vaginal pH measurement [Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)]
• Vaginal Health Index Score (VHIS): vaginal epithelial integrity score [Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)]
• Vaginal Health Index Score (VHIS): vaginal moisture score [Time frame: baseline (M0), 3, 6 and 12 months (M3, M6, M12)]
• Side effects of radiofrequency treatment [Time frame: through study completion: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 1 center

• Centre Oscar Lambret — Lille

Publications

• Faubion SS, Sood R, Kapoor E. Genitourinary Syndrome of Menopause: Management Strategies for the Clinician. Mayo Clin Proc. 2017 Dec;92(12):1842-1849. doi: 10.1016/j.mayocp.2017.08.019. PMID 29202940
• Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014 Oct;21(10):1063-8. doi: 10.1097/GME.0000000000000329. PMID 25160739
• Moral E, Delgado JL, Carmona F, Caballero B, Guillan C, Gonzalez PM, Suarez-Almarza J, Velasco-Ortega S, Nieto C; as the writing group of the GENISSE study. Genitourinary syndrome of menopause. Prevalence and quality of life in Spanish postmenopausal women. The GENISSE study. Climacteric. 2018 Apr;21(2):167-173. doi: 10.1080/13697137.2017.1421921. Epub 2018 Feb 7. PMID 29411644
• Simon JA, Davis SR, Althof SE, Chedraui P, Clayton AH, Kingsberg SA, Nappi RE, Parish SJ, Wolfman W. Sexual well-being after menopause: An International Menopause Society White Paper. Climacteric. 2018 Oct;21(5):415-427. doi: 10.1080/13697137.2018.1482647. Epub 2018 Jul 10. PMID 29987939
• Nappi RE, Cucinella L, Martella S, Rossi M, Tiranini L, Martini E. Female sexual dysfunction (FSD): Prevalence and impact on quality of life (QoL). Maturitas. 2016 Dec;94:87-91. doi: 10.1016/j.maturitas.2016.09.013. Epub 2016 Sep 28. PMID 27823751
• Kaur N, Gupta A, Sharma AK, Jain A. Survivorship issues as determinants of quality of life after breast cancer treatment: Report from a limited resource setting. Breast. 2018 Oct;41:120-126. doi: 10.1016/j.breast.2018.07.003. Epub 2018 Jul 11. PMID 30029054
• Oyarzun MFG, Castelo-Branco C. Local hormone therapy for genitourinary syndrome of menopause in breast cancer patients: is it safe? Gynecol Endocrinol. 2017 Jun;33(6):418-420. doi: 10.1080/09513590.2017.1290076. Epub 2017 Feb 21. PMID 28277141
• Lubian Lopez DM. Management of genitourinary syndrome of menopause in breast cancer survivors: An update. World J Clin Oncol. 2022 Feb 24;13(2):71-100. doi: 10.5306/wjco.v13.i2.71. PMID 35316932

Identifiers

NCT: NCT06900374 · RF-Vaginale-2401 · API-23-18 · 2024-A01126-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗