Clinical trial · Interventional
CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer
CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer A Comparative, Randomized, Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Genitourinary Syndrome of Menopause | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fractional/Pixel CO2 laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Laser treatment
- description
- Each patient will be treated once every 20-40 days, for a total of 3 laser treatments. In every visit during the study, patients will undergo gynecological examination and will complete questionnaires evaluating GSM symptoms, using a visual analogue scale (VAS) for each symptom (vaginal dryness, dyspareunia, discharge, itching and/or stinging, vaginal bleeding and dysuria) as well as treatment induced pain and side effects.
- interventionNames
- Device: Fractional/Pixel CO2 laser
- type
- SHAM_COMPARATOR
- label
- Sham treatment
- description
- Each patient will be treated once every 20-40 days, for a total of 3 Sham treatments, in a similar procedure not using an active laser energy. Patients will be assessed in a similar manner. Following 3 Sham-treatments patients in the placebo group will be offered the laser treatment in an open-label study .
- interventionNames
- Device: Fractional/Pixel CO2 laser
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Patients diagnosed with breast cancer 2. Menopause: spontaneous, surgical or chemotherapy induced 3. One or more GSM Symptoms: dryness, irritation, burning, pain, dyspareunia, dysuria 4. On exam, clinical findings of atrophy: thin, dry, pale vagina 5. Age\>18 6. Normal Pap smear within 3 years Exclusion criteria: 1. Menstruation 2. Chemotherapy 3. Vaginal bleeding which did not underwent evaluation 4. Concurrent treatment with topical estrogen 5. Previous vulvar, vaginal or cervical dysplasia\\ cancer
References
Publications (0)
Data not yet available