Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

Not Applicable

Not yet recruiting

• Conditions: Vaginal Dryness; Breast Cancer; Vulvovaginal Atrophy

• Registration Number: NCT06900374
• Lead Sponsor: Centre Oscar Lambret

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.

Study Timeline

• Study First Submitted: 2025-02-24
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-27
• Study First Posted: 2025-03-28
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Study Start: 2025-05-01
• Primary Completion: 2028-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France