Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorCentre Oscar Lambret
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Ongoing urinary tract infection
Pacemaker
IUD intrauterine device
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
GynWave-360
DeviceFor 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).
Local hydratation
Other interventionReference 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.).
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Vaginal radiofrequency treatmentExperimental treatment 2 interventions
Group B: Reference treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 outcomes
1
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
Time frame
baseline (M0), 3, 6 and 12 months (M3, M6, M12)2
Vaginal Health Index Score (VHIS) : vaginal elasticity score
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.
Time frame
baseline (M0), 3, 6 and 12 months (M3, M6, M12)3
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: 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.
Time frame
baseline (M0), 3, 6 and 12 months (M3, M6, M12)4
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: 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.
Time frame
baseline (M0), 3, 6 and 12 months (M3, M6, M12)Other outcomes
1
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.
Time frame
through study completion: 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Oscar Lambret
Lead sponsor
MATMATECH
Collaborator
Source ClinicalTrials.gov