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| ID | Type | Description | Link |
|---|---|---|---|
| API-23-18 | Other Grant/Funding Number | DGOS/INCA | |
| 2024-A01126-41 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| MATMATECH | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Rated 0-10 numerical scale for dyspareunia | 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 | baseline (M0), 3, 6 and 12 months (M3, M6, M12) |
| Vaginal Health Index Score (VHIS) : vaginal elasticity score |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of discontinuation or modification of hormone therapy | - 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. | through study completion: 12 months |
INCLUSION CRITERIA :
EXCLUSION CRITERIA:
Contraindications related to the radiofrequency technique:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fanny BEN OUNE | Contact | +33320295896 | promotion@o-lambret.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julie DEMETZ, MD | Centre Oscar Lambret | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Recruiting | Lille | 59020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29202940 | Background | 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. | |
| 25160739 | Background | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
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
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| 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.). |
|
Vaginal elasticity is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:
Higher scores indicate better vaginal elasticity. |
| baseline (M0), 3, 6 and 12 months (M3, M6, M12) |
| Vaginal Health Index Score (VHIS) : vaginal fluid volume score | Vaginal fluid volume is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:
| baseline (M0), 3, 6 and 12 months (M3, M6, M12) |
| Vaginal Health Index Score (VHIS) : vaginal pH measurement | Vaginal pH is measured using a pH test strip applied to the vaginal mucosa by a physician observer. The pH is categorized as follows:
| baseline (M0), 3, 6 and 12 months (M3, M6, M12) |
| Vaginal Health Index Score (VHIS): vaginal epithelial integrity score | Epithelial integrity is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:
| baseline (M0), 3, 6 and 12 months (M3, M6, M12) |
| Vaginal Health Index Score (VHIS): vaginal moisture score | Vaginal moisture is assessed by a physician observer blinded to the treatment group. It is scored on a 5-point scale:
| baseline (M0), 3, 6 and 12 months (M3, M6, M12) |
| Side effects of radiofrequency treatment | 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. | through study completion: 12 months |
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| D017437 |
| Skin and Connective Tissue Diseases |