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

NCT05585476 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-09-19

No results posted yet for this 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.

Conditions

  • Female Urogenital Diseases
  • Breast Cancer Female

Interventions

DEVICE

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.

COMBINATION_PRODUCT

Regenerative topical treatment

It is a moisturizing and regenerating gel whose active ingredients are olive oil, trimethylglycine and xylitol.

Sponsors & Collaborators

  • Lumenis Be Ltd.

    collaborator INDUSTRY

  • Mucosa Innovations, S.L.

    collaborator INDUSTRY

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Amalia Cañadas Molina · Employee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-06-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05585476 on ClinicalTrials.gov