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Recruiting Not applicable

A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.

NCT05585476 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2025-10-15
Last updated
2026-09-29

Condition(s) studied

Female Urogenital DiseasesBreast Cancer Female

Investigational drug(s) / intervention(s)

C02 microablative laserRegenerative topical treatment

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

Sex
FEMALE
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: Patients must meet ALL of the following criteria to be included in the study: 1. Patients over 18 years of age 2. Who have a history of breast malignancy, and are on adjuvant or neoadjuvant treatment with hormone therapy. 3. That they suffer symptoms related to vulvo-vaginal atrophy and thus become evident to the gynecological examination (Vaginal Health Index\<ó=15). 4. That this clinic significantly affects your quality of life ( score in Sexual Function-Vaginal Changes Questionnaire less than or equal to 24 points). 5. Who have not received any treatment for vulvo-vaginal atrophy in at least the previous 6 months. Purely moisturizing or emollient treatments that do not contain any regenerating substance (hyaluronic acid, gotu kola, vitamin E or rosehip oil) are not considered exclusive. 6. That they agree to participate and give their written I consent. Exclusion Criteria: Patients who present ANY of the following criteria may not be selected to participate in this study: 1. Medical or surgical history that at the discretion of the researcher does not allow participation in the study. 2. Refusal to participate in the study and to sign consent. 3. Be on chemotherapy treatment at the time of inclusion in the study. 4. Have completely completed the adjuvant hormonal treatment. 5. Have a history of vulvar, vaginal and/or cervical malignancy. 6. Have received radiation therapy to the pelvic and/or genital region. 7. Sjögren's syndrome and other pathologies that occur with mucosal involvement. 8. Present any type of disease that occurs with alteration of collagenogenesis. 9. Intake of other cytotoxic drugs that lead to mucositis and alterations of tissue regeneration in the last 6 months. 10. Have previously received laser and/or radiofrequency treatment for the treatment of genital atrophy or other pelvic floor dysfunctions. 11. Active urinary and/or genital tract infection. 12. Diagnosis of gestation at the time of recruitment. 13. History of malignant neoplasm of the urinary tract. 14. Have severe stress urinary incontinence (Sandvik test with a score equal to or greater than 8) 15. Diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification. 16. Any other condition which, in the opinion of the investigator, means that the patient is not in a position to understand the implication of participating in the study and/or of following the established procedures.

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)

FacilityCityRegionStatus
Hospital Universitario Fundación Jiménez Díaz Madrid Spain Recruiting
Official registry record

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