Breast Cancer, Vaginal Dryness, Vulvovaginal Atrophy
Conditions
Keywords
Vaginal dryness, vaginal atrophy, vaginal radiofrequency, breast cancer
Brief summary
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
DEVICEGynWave-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).
OTHERLocal 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.).
Sponsors
Centre Oscar Lambret
MATMATECH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical scale for vaginal dryness according to patient | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient-Rated 0-10 numerical scale for dyspareunia | 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 |
| Vaginal Health Index Score (VHIS) : vaginal elasticity score | 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: 1. = None 2. = Poor 3. = Fair 4. = Good 5. = Excellent Higher scores indicate better vaginal elasticity. |
| Vaginal Health Index Score (VHIS) : vaginal fluid volume score | 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: 1. = None 2. = Scar amount (vault not entirely covered) 3. = Superficial amount (vault entirely covered) 4. = Moderate amount 5. = Normal amount Higher scores indicate greater fluid volume, which reflects better vaginal hydration. |
| Vaginal Health Index Score (VHIS) : vaginal pH measurement | 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: 1. = ≥6.1 2. = 5.6-6.0 3. = 5.1-5.5 4. = 4.7-5.0 5. = ≤4.6 Lower values indicate a healthier vaginal environment. |
| Vaginal Health Index Score (VHIS): vaginal epithelial integrity score | 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: 1. = Petechiae noted before contact 2. = Bleeds with light contact 3. = Bleeds with scraping 4. = Not friable (thin epithelium) 5. = Normal Higher scores indicate better vaginal epithelial integrity. |
| Vaginal Health Index Score (VHIS): vaginal moisture score | 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: 1. = None (surface inflamed) 2. = None (surface non-inflamed) 3. = Minimal 4. = Moderate 5. = Normal Higher scores indicate better vaginal moisture levels. |
| Side effects of radiofrequency treatment | 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. |
Countries
France
Contacts
CONTACTFanny BEN OUNE
STUDY_DIRECTORJulie DEMETZ, MD
Centre Oscar Lambret
Outcome results
None listed