NCT05585476 A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.
| NCT ID | NCT05585476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
| Condition | Female Urogenital Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 195 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 195 participants in total. It began in 2025-10-15 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Amalia Cañadas Molina
PRINCIPAL INVESTIGATOR
Employee
Frequently Asked Questions
Who can join the NCT05585476 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Female Urogenital Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05585476 currently recruiting?
Yes, NCT05585476 is actively recruiting participants. Contact the research team at amalia.canadas@fjd.es for enrollment information.
Where is the NCT05585476 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT05585476 clinical trial?
NCT05585476 is sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. The principal investigator is Amalia Cañadas Molina at Employee. The trial plans to enroll 195 participants.