Effectiveness of C02 Microfractionated Laser in Conjunction With Topical Regenerative Therapy in the Management of Vulvo-vaginal Atrophy in Patients With a History of Breast Cancer. Randomized Experimental and Comparative Study.

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz0 个研究点目标入组 180 人开始时间: 2025年10月1日最近更新: 2025年9月19日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 180
主要终点: Presence of symptoms at the vulvovaginal level and their intensity

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

Based on the hypothesis set out in the previous section, the main objective of the study will consist of:

-To assess the effectiveness of microfractionated C02 laser therapy in combination with non-hormonal topical regenerative therapy versus laser treatment or non-hormonal topical regenerative treatment (the latter two exclusively) in the management of symptoms derived from vulvovaginal atrophy in cancer patients who are contraindicated to the use of hormonal therapies.

As secondary objectives we have the following:

To determine the prevalence and incidence of genitourinary syndrome in our population of patients diagnosed with breast cancer and who are undergoing adjuvant or neoadjuvant treatment (with the exception of chemotherapy).
To assess the impact of genitourinary syndrome on the quality of life of these patients.
To determine the degree of correlation between intensity of the symptomatology and impact on the quality of life of the same with the presence of characteristic changes of hormonal depletion at the tissue level and vaginal microbiota.
To evaluate the safety and tolerability of the C02 laser in our group of patients. Special attention will be paid to the occurrence of adverse events that have not been described in the literature at the present time.
Describe other effects of laser treatment on urinary symptoms that could serve as hypotheses for future studies.
To evaluate the safety and tolerability of the topical non-hormonal regenerating agent XCM intim in our group of patients.
To describe the effects of topical non-hormonal regenerative therapy on vulvo-vaginal and urinary symptoms and the impact on the quality of life of these patients.

To carry out all the above, it is proposed to perform a controlled and randomized clinical trial, single blind, in which the patients included will be assigned to one of the 3 existing treatment arms and that we will explain in detail in later sections.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Outcomes Assessor)

盲法说明

In order to mask the patients from the treatment group to which they have been assigned, a simulated laser treatment session will be carried out in the case of patients belonging to the topical regenerative treatment group, which will consist of keeping the device turned off during it but faithfully reproducing both the duration as the sounds emitted by the device through recording previously made. In the case of patients assigned to laser treatment exclusively, they will be provided with a topical placebo (water-based), which must be applied with the same regimen as the emollient treatment under study.

入排标准

年龄范围: 18 Years 至 100 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Patients must meet ALL of the following criteria to be included in the study:
•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).
•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.
•That they agree to participate and give their written I consent.

排除标准

•Patients who present ANY of the following criteria may not be selected to participate in this study:
•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.
•Have a history of vulvar, vaginal and/or cervical malignancy.
•Have received radiation therapy to the pelvic and/or genital region.
•Sjögren's syndrome and other pathologies that occur with mucosal involvement.
•Present any type of disease that occurs with alteration of collagenogenesis.
•Intake of other cytotoxic drugs that lead to mucositis and alterations of tissue regeneration in the last 6 months.
•Have previously received laser and/or radiofrequency treatment for the treatment of genital atrophy or other pelvic floor dysfunctions.
•Active urinary and/or genital tract infection.
•Diagnosis of gestation at the time of recruitment.
•History of malignant neoplasm of the urinary tract.
•Have severe stress urinary incontinence (Sandvik test with a score equal to or greater than 8)
•Diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.
•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.