Clinical trial NCT04081805: LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)
Official title: LASER and Radiofrequency as Alternative Treatment of Vaginal Vulvar Atrophy in Women Treated for Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vaginal Atrophy
Vulva; Atrophy
Breast Cancer
Keywords: LASER
Radiofrequency
Vulvovaginal atrophy
breast cancer
treatment
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-09-09
Enrollment: 195
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and promestriene
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Improvement of signs and symptoms of vulvovaginal atrophy with intravaginal LASER, Micro Ablative Radiofrequency, and topic promestriene
timeFrame: The evaluation will be done 90 days after treatment]
measure: Satisfaction with treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic promestriene for women treated for breast cancer, with genitourinary atrophy syndrome
timeFrame: The evaluation will be done 90 days after treatment
Secondary outcomes:
measure: Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic promestriene
timeFrame: The evaluation will occur pre-treatment 30, 90 , 180 and 360 days after treatment]
measure: Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic promestriene
timeFrame: The evaluation will occur pre-treatment and 30, 90, 180 and 360 days after treatment
measure: Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.
timeFrame: The evaluation will occur pre-treatment and 30 and 180 days after treatment
measure: Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.
timeFrame: The evaluation will occur pre-treatment and 30 and 180 and 360 days after treatment]
measure: Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.
timeFrame: The evaluation will occur pre-treatment and 30 180 and 360 days after treatment
measure: Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.
timeFrame: The evaluation will occur pre-treatment and 30 and 180 days after treatment]
measure: Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.
timeFrame: The evaluation will occur pre-treatment and 30 and 180 days after treatment
measure: Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.
timeFrame: The pictures will be taken before and 30 days and 180 days after treatment.]
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo - Unifesp
state: SP
Study officials:
affiliation: Professor
name: Zsuzsanna IK Jarmy-di Bella, PhD
role: STUDY_CHAIR
affiliation: Professor and Head of Gynecology Department
name: Marair GF Sartori, PhD
role: STUDY_DIRECTOR
References: