LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)

N/AActive Not RecruitingNCT04081805

Federal University of São Paulo195 enrolled

Overview

This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.

Women treated for breast cancer with moderate or severe signs or symptoms of vulvovaginal atrophy will be eligible for the study. The patients will be randomized to receive one of the three intravaginal therapies: LASER, Micro Ablative radiofrequency or Promestriene. The applications will occur in the interval of 30 days for 3 times, for LASER and Radiofrequency groups. For the promestriene group, the application will be done by the patient, daily for 2 weeks and then twice a week for 3 months, and each 30 days, the patients will have an appointment when will be checked the weight of the promestriene tube, to verify the correct use. The follow-up visits will occur 30, 90, 180 and 360 days after the conclusion of the third month of treatment. Will be evaluated: vulvar and vaginal histology before and after the use of LASER, radiofrequency or estriol; microbiota and vaginal pH before and after the use of LASER, radiofrequency or promestriene; extracellular matrix and metalloproteinases in the remodeling of vulvovaginal collagen induced by promestriene, LASER and radiofrequency; quality of life, sexual dysfunctions and complains before and after the use of LASER, radiofrequency or hormones; metabolomics and vaginal microbiome.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

195

Conditions

Vaginal Atrophy Vulva; Atrophy Breast Cancer

Interventions

LASERPROCEDURE

The patient will use intravaginal estriol, daily for 2 weeks and them twice a week for 3 months . Each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube to verify the correct use.vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured.

Micro Ablative RadiofrequencyPROCEDURE

Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured

Promestriene

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women with breast cancer treated with surgery and / or chemotherapy and / or radiotherapy, that has been concluded at least 6 months before inclusion, whether or not using aromatase inhibitor and complaining of vulvovaginal atrophy 2. To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of vulvovaginal atrophy: * Burning * Discomfort * Dryness * Cracks * Pruritus * Lack of vaginal lubrication * Penetration dyspareunia that began at the menopausal or postmenopausal transition * Decreased vaginal epithelium turgor and trophism * Deletion of mucous and skin folds. 3. Absence of vaginal surgical procedure in the last year 4. Genital prolapse stage no greater than stage II of Pelvic Organs Prolapse Quantitation (POP-Q) with Ba, Bp or C points less than or equal to 0 Exclusion Criteria: 1. Active genital infection 2. Active infection of HPV (human papillomavirus) or Herpes 3. users of medications with estrogenic effect (digoxin and other chemicals) 4. Postmenopausal genital bleeding 5. uncontrolled diabetes 6. use of multivitamins with zinc 7. use of copper or hormonal IUDs (intrauterine device) at the time of inclusion 8. presence of genitourinary or rectovaginal fistulas

Locations (1)

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Clinical Improvement of signs and symptoms of vulvovaginal atrophy with intravaginal LASER, Micro Ablative Radiofrequency, and topic promestriene

Will be applied a Visual Analogic Scale (0-10) to access the improvement of genitourinary signs and symptoms, the results of the three groups will be compared

Time frame: The evaluation will be done 90 days after treatment]

Satisfaction with treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic promestriene for women treated for breast cancer, with genitourinary atrophy syndrome

Will be applied a LIKERT Satisfaction Scale (1-5) to access the satisfaction with the treatment, the results of the three groups will be compared

Time frame: The evaluation will be done 90 days after treatment

Secondary Outcomes

Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic promestriene

The vaginal flora will be evaluated by vaginal smear. The results of the three groups will be compared

Time frame: The evaluation will occur pre-treatment 30, 90 , 180 and 360 days after treatment]

Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic promestriene

The vaginal pH will be verified by the use of pH tape's. The results of the three groups will be compared

Time frame: The evaluation will occur pre-treatment and 30, 90, 180 and 360 days after treatment

Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

Thickness of epithelium (mm and number of layers), and evaluation of expression of Ki-67 and VEGF (vascular endothelial growth factor) will be done on vaginal and vulvar biopsies, in order to evaluate the tissue regeneration ( a greater the number of layers associated with the expression of VEGF and ki67 indicate a tissue regeneration, the combination of this measures, and not evaluation each one isolated, are important to evaluate histological improvement). The results of the three groups will be compared

Data from ClinicalTrials.gov

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