Clinical trial
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.
Name
FJD-LCO2-19-01
Description
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.
Trial arms
Trial start
2024-06-01
Estimated PCD
2024-09-01
Trial end
2026-06-01
Status
Not yet recruiting
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.
Arms:
Laser + Regenerative topical treatment, Laser treatment
Regenerative topical treatment
It is a moisturizing and regenerating gel whose active ingredients are olive oil, trimethylglycine and xylitol.
Arms:
Laser + Regenerative topical treatment, Regenerative topical treatment
Size
180
Primary endpoint
Presence of symptoms at the vulvovaginal level and their intensity
From prior consultation at the beginning of treatment to 24 months after it ends.
Impact in the quality of life of vulvo-vaginal symptoms.
From prior consultation at the beginning of treatment to 24 months after it ends.
Changes in vulvar physical examination
From prior consultation at the beginning of treatment to 24 months after it ends.
Changes in vaginal physical examination
From prior consultation at the beginning of treatment to 24 months after it ends.
Thickness of the vaginal epithelium
From prior consultation at the beginning of treatment to 24 months after it ends.
Quantification of cellular glycogen
From prior consultation at the beginning of treatment to 24 months after it ends.
Number of capillaries in vaginal mucosa
From prior consultation at the beginning of treatment to 24 months after it ends.
Amount of Lactobacillus in vaginal microbiota
From prior consultation at the beginning of treatment to 24 months after it ends.
Amount of Candida spp in vaginal microbiota
From prior consultation at the beginning of treatment to 24 months after it ends.
Amount of Gardnerella vaginalis in vaginal microbiota
From prior consultation at the beginning of treatment to 24 months after it ends.
Free glycogen detection in vaginal discharge
From prior consultation at the beginning of treatment to 24 months after it ends.
Vaginal pH
From prior consultation at the beginning of treatment to 24 months after it ends.
Skin elasticity
From prior consultation at the beginning of treatment to 24 months after it ends.
Amount of transdermal water in the skin
From prior consultation at the beginning of treatment to 24 months after it ends.
Skin pigmentation
From prior consultation at the beginning of treatment to 24 months after it ends.
Degree of vascularization of the skin
From prior consultation at the beginning of treatment to 24 months after it ends.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single-blind, randomized, controlled clinical trial is proposed, in which the patients included will be assigned to one of the three treatment arms.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}
Updated at
2024-04-23
1 organization
1 product
2 indications
Indication
Female Urogenital DiseasesIndication
Breast Cancer