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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Numerical scale for vaginal dryness according to patient
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Vaginal radiofrequency treatment
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.
干预措施: GynWave-360 (Device)
Vaginal radiofrequency treatment
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.
干预措施: Local hydratation (Other)
Reference treatment
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).
干预措施: Local hydratation (Other)
结局指标
主要结局
Numerical scale for vaginal dryness according to patient
时间窗: 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.
次要结局
- 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))
- Vaginal Health Index Score (VHIS): vaginal moisture score(baseline (M0), 3, 6 and 12 months (M3, M6, M12))
- Side effects of radiofrequency treatment(through study completion: 12 months)