A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Condition(s) studied
Investigational drug(s) / intervention(s)
C02 microablative laser: The C02 microablative laser was the first to be used in the treatment of menopausal genitourinary syndrome. Its mechanism of action is based on the emission of light at a wavelength of 10600nm that is absorbed by the water molecules contained in the vaginal mucosa, leading to local remodeling of connective tissue and neoformation of collagen, elastic fibers and other components of the extracellular matrix.
Regenerative topical treatment: It is a moisturizing and regenerating gel whose active ingredients are olive oil, trimethylglycine and xylitol.
Study summary
The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.
Eligibility
Primary outcome measure(s)
- Presence of symptoms at the vulvovaginal level and their intensity — From prior consultation at the beginning of treatment to 6 months after it ends.
This group will include the following items: * Pain with sexual intercourse (dyspareunia). * Feeling of vaginal stiffness. * Dryness. * Vulvar itching. * Vulvar and/or vaginal burning. * Urinary frequency (more than 8 times a day). * Burning when urinating (dysuria). The way to measure the intensity of these symptoms will be through Visual Analog Scale Of Symptom Intensity, with absolute values ranging from 0 to 10. We will consider improvement a reduction of 2 or more points in at least 50% of the items. Meeting only this item is already considered an efficacy criterion.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05585476 on ClinicalTrials.gov ↗ ← All trials in Spain