Comparing CO2 and Erbium:YAG lasers for treating vaginal symptoms in breast cancer patients
Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of Genitourinary Syndrome of Menopause (GSM) in Patients Using Aromatase Inhibitors: Double Blinded Randomized Controlled Clinical Trial.
This study is testing whether two types of lasers can help women with breast cancer who are having vaginal symptoms feel better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Leuven, Flemish Brabant) |
| Trial ID | NCT05713435 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of two types of intravaginal lasers, CO2 laser and Erbium:YAG laser, in alleviating genitourinary symptoms in patients undergoing treatment with aromatase inhibitors for breast cancer. Participants will be women who are experiencing moderate to severe symptoms of genitourinary syndrome of menopause due to iatrogenic menopause. The study will compare the outcomes of the two laser treatments against a sham application to determine which is more beneficial for symptom relief.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women with a history of breast cancer who are currently menopausal and experiencing moderate to severe genitourinary symptoms while on aromatase inhibitors.
Not a fit: Patients with acute urinary or genital infections, or those who have recently used hormonal therapies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-hormonal treatment options for vaginal dryness in breast cancer survivors.
How similar studies have performed: Other studies have shown promising results with laser treatments for similar conditions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Recruited participants will meet all of these criteria: * a history of breast cancer * premenopausal at diagnosis of breast cancer * using AI as an adjuvant treatment * moderate to severe symptoms of GSM (VAS ≥ 4/10) * currently menopausal, which can be either biochemical menopause as confirmed after chemotherapy, surgical or medicinally induced (GnRH analogues for the duration of the trial) Exclusion Criteria: * Not willing to abstain from vaginal intercourse for 1 week following laser therapy * Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion * Use of hormonal therapy within 6 months prior to inclusion (systemic or local) * Acute urinary or genital tract infections * A history of genital fistula, a thin rectovaginal septum as determined by the investigator, or history of fourth degree laceration * Prolapse ≥ grade 2 according to the Pelvic Organ Prolapse Quantification System * Previous vaginal mesh implantation * Abnormal result in the last cervical smear (maximum 36 month before enrollment) * Active cancer treatment (radiotherapy or chemotherapy) ongoing or planned prior to the measurement of the primary outcome (6 months after inclusion, 3 months after last laser) * Vaginal stenosis that does not allow the placement of the laser probe * Any condition that could interfere with study compliance
Where this trial is running
Leuven, Flemish Brabant
- UZ Leuven — Leuven, Flemish Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Susanne Housmans, MD — UZ Leuven
- Study coordinator: Susanne Housmans, MD
- Email: susanne.housmans@uzleuven.be
- Phone: +3216332211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.