A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz • ClinicalTrials.gov ID: NCT05585476
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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.
Interventions
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C02 microablative laser
(Device)
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.
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Regenerative topical treatment
(Combination product)
It is a moisturizing and regenerating gel whose active ingredients are olive oil, trimethylglycine and xylitol.
Eligibility criteria
Conditions
Locations
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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