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

Federal University of São Paulo

Status: Active, not recruiting

Conditions: Breast Cancer; Vaginal Atrophy; Vulva; Atrophy

Treatments: Procedure: Micro Ablative Radiofrequency; Drug: Promestriene; Procedure: LASER

Study type: Interventional

Funder types: Other

Identifiers

NCT04081805

CEP0431/2018 arm 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 estimated patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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195 participants in 3 patient groups

LASER

Active Comparator group

Description:

The patients will receive 3 consecutive applications of intravaginal and vulvar CO2 LASER, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days

Treatment:

Procedure: LASER

Micro Ablative Radiofrequency

Active Comparator group

Description:

The patients will receive 3 consecutive applications of intravaginal and vulvar MIcroablative radiofrequency, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days

Treatment:

Procedure: Micro Ablative Radiofrequency

Promestriene

Active Comparator group

Description:

The patient will use intravaginal promestriene, 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 promestriene tube to verify the correct use.

Treatment:

Drug: Promestriene