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

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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