Symptoms of vulvovaginal atrophy, notably vaginal dryness, are common in patients treated for breast cancer, affecting up to 73% of this population. Many breast cancer therapies induce oestrogen deprivation in the genital tract, which can generate or worsen these symptoms. The source article emphasizes that vulvovaginal atrophy is frequently underdiagnosed and undertreated and that when present it can meaningfully impair quality of life and contribute to premature discontinuation of adjuvant endocrine therapy.
Current guideline-consistent first-line care for vulvovaginal atrophy in patients with breast cancer is non-hormonal local moisturising therapy. The protocol describes a hyaluronic acid–based moisturiser used three times weekly as the reference treatment. Systemic menopausal hormone therapy is not indicated in this neoplastic context, and local oestrogen is not considered a first-line option for patients managed for breast cancer. Because moisturising therapy alone is often insufficient, alternative non-hormonal modalities are under consideration. One such option is vaginal radiofrequency (RF), a device-based therapy that aims to stimulate fibroblasts and increase collagen synthesis in the vaginal tissue, potentially improving symptoms of dryness and related signs.
The authors note that vaginal RF has not been sufficiently evaluated in the published literature, motivating the RF-Vaginale trial to test whether adding RF to standard moisturising care can improve patient-reported vaginal dryness after breast cancer treatment.
RF-Vaginale is described as a multicentre, randomised phase III trial with two parallel groups assessed through 6 months and with additional follow-up at 3 and 12 months. Participants will be randomised to one of two arms:
Reference treatment: a hyaluronic acid–based local moisturiser, applied three times per week.
Experimental treatment: the same reference moisturising regimen plus vaginal RF treatment. The RF device specified in the protocol is MATMATECH, GynWave 360. The RF intervention consists of three treatment sessions, each session spaced 4–6 weeks apart.
Physicians assessing some outcomes will be blinded to treatment allocation as specified below.
The trial will be offered to patients receiving adjuvant treatment for breast cancer that includes an aromatase inhibitor with or without a luteinising hormone‑releasing hormone (LHRH) agonist. The source document does not report additional inclusion or exclusion criteria, nor the planned sample size or recruitment targets.
Primary outcome:
Secondary outcomes:
Dyspareunia, measured by the patient on a 0–10 numerical scale. This secondary outcome will be assessed only in participants who report having a sexual life that includes vaginal intercourse with a male partner.
Vaginal Health Index Score (VHIS), assessed by a physician who is blinded to the patient’s treatment allocation.
Timing of assessments:
The source article does not provide details on additional patient-reported outcome instruments, adverse event reporting procedures, or thresholds for clinically meaningful change.
The primary analysis described in the protocol will evaluate the mean difference in the vaginal dryness score at 6 months between the two arms, with adjustment for the baseline vaginal dryness score and for patient age. The source does not disclose sample size calculation parameters, power assumptions, handling of missing data, multiplicity adjustments, or detailed secondary analysis plans.
Ethical review and approvals:
The protocol received ethics committee approval from CPP Sud Est I on 12 November 2024. The study is stated to comply with the Declaration of Helsinki, French laws and regulations, and the International Conference on Harmonisation E6 Guideline for Good Clinical Practice (reference EMA/CHMP/ICH/135/1995). The trial is registered under number NCT06900374.
Dissemination plans:
Investigators plan to present the trial results at international oncology congresses and to publish findings in peer‑reviewed journals regardless of whether the results are conclusive.
The source text omits several operational and methodological details commonly reported in full protocols. Specific items not reported in the provided summary include:
These missing details were not reported in the source and therefore are not summarized here.
The RF-Vaginale protocol describes a multicentre randomised phase III trial testing whether adding vaginal radiofrequency (MATMATECH, GynWave 360; three sessions) to standard hyaluronic acid–based moisturising therapy improves patient‑reported vaginal dryness at 6 months in patients on adjuvant aromatase inhibitor therapy ± LHRH agonist. Primary and key secondary outcomes include patient-rated dryness and dyspareunia and physician‑assessed VHIS, with assessments at 3, 6, and 12 months. The trial has ethical approval and a registered identifier; additional protocol details were not provided in the source summary.