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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz

About this trial

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

Qualifiers

Patients over 18 years of age

Who have a history of breast malignancy, and are on adjuvant or neoadjuvant treatment with hormone therapy.

That they suffer symptoms related to vulvo-vaginal atrophy and thus become evident to the gynecological examination (Vaginal Health Index<ó=15).

That this clinic significantly affects your quality of life ( score in Sexual Function-Vaginal Changes Questionnaire less than or equal to 24 points).

Disqualifiers

Medical or surgical history that at the discretion of the researcher does not allow participation in the study.

Refusal to participate in the study and to sign consent.

Be on chemotherapy treatment at the time of inclusion in the study.

Have completely completed the adjuvant hormonal treatment.

Trial design

Treatments tested in this trial

  • C02 microablative laser
  • Regenerative topical treatment

Treatment groups

180 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Lead sponsor

Lumenis Be Ltd.

Collaborator

Mucosa Innovations, S.L.

Collaborator