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

Primary Purpose

Vaginal Atrophy, Vulva; Atrophy, Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

LASER

Micro Ablative Radiofrequency

Promestriene

About this trial

This is an interventional treatment trial for Vaginal Atrophy focused on measuring LASER, Radiofrequency, Vulvovaginal atrophy, breast cancer, treatment

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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
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.
Absence of vaginal surgical procedure in the last year
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:

Active genital infection
Active infection of HPV (human papillomavirus) or Herpes
users of medications with estrogenic effect (digoxin and other chemicals)
Postmenopausal genital bleeding
uncontrolled diabetes
use of multivitamins with zinc
use of copper or hormonal IUDs (intrauterine device) at the time of inclusion
presence of genitourinary or rectovaginal fistulas

Sites / Locations

Federal University of Sao Paulo - UnifespRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

LASER

Micro Ablative Radiofrequency

Promestriene

Arm 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

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

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

The IQol (incontinence quality of life questionnaire, validated to portuguese language - score 0-100) will be used to evaluate quality of life .The results of the three groups will be compared

Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

The FSF-I (Female Sexual Function Index , validated to portuguese language- score range from 2 - 36) will be used to evaluate sexual function . The results of the three groups will be compared

Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

Evaluation of the composition and concentration of the glycosaminoglycans of extracellular matrix in the vaginal and vulvar biopsies by specific markers. The results of the three groups will be compared

Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

Evaluation of the tissue distribution of the MMP-1, MMP-2, MMP-3, MMP-7, MMP-9 metalloproteinases of collagen I, II, IV and elastin proteins by specific markers on vaginal and vulvar biopsies. The results of the three groups will be compared

Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

Pictures of vulva will be taken before and after treatment. The images will be evaluated by a blind gynecologist and dermatologist regarding the type of treatment and the chronological order of the photos, which will classify the images as: better; equal or worse, in relation to tropism and number of vulvar skin grooves, The results of the three groups will be compared

Full Information

NCT ID

NCT04081805

First Posted

August 8, 2019

Last Updated

September 12, 2023

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT04081805

Brief Title

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

Acronym

EPMLARF

Official Title

LASER and Radiofrequency as Alternative Treatment of Vaginal Vulvar Atrophy in Women Treated for Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 30, 2019 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Atrophy, Vulva; Atrophy, Breast Cancer

Keywords

LASER, Radiofrequency, Vulvovaginal atrophy, breast cancer, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and promestriene

Masking

InvestigatorOutcomes Assessor

Masking Description

the outcomes assessor will not have access to the treatment that was used in each patient. the investigator will not have acess to the treatment that was used in each group

Allocation

Randomized

Enrollment

195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LASER

Arm Type

Active Comparator

Arm Description

Arm Title

Micro Ablative Radiofrequency

Arm Type

Active Comparator

Arm Description

Arm Title

Promestriene

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

LASER

Other Intervention Name(s)

Fractional Co2 (carbon dioxide)Laser, MonaLisa Touch® treatment, SmartXide Touch V²LR® Deka

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Micro Ablative Radiofrequency

Other Intervention Name(s)

FRAAX, Linly™ Loktal Medical Electronics

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Promestriene

Other Intervention Name(s)

Vaginal Promestriene

Intervention Description

The patient will perform self application of this vaginal promestriene daily for 2 weeks and after that the applications will occur twice a week.

Primary Outcome Measure Information:

Title

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

Description

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]

Title

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

Description

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 Outcome Measure Information:

Title

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

Description

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]

Title

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

Description

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

Title

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

Description

Time Frame

The evaluation will occur pre-treatment and 30 and 180 days after treatment

Title

Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

Description

The IQol (incontinence quality of life questionnaire, validated to portuguese language - score 0-100) will be used to evaluate quality of life .The results of the three groups will be compared

Time Frame

The evaluation will occur pre-treatment and 30 and 180 and 360 days after treatment]

Title

Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

Description

The FSF-I (Female Sexual Function Index , validated to portuguese language- score range from 2 - 36) will be used to evaluate sexual function . The results of the three groups will be compared

Time Frame

The evaluation will occur pre-treatment and 30 180 and 360 days after treatment

Title

Evaluation of extracellular matrix before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

Description

Time Frame

The evaluation will occur pre-treatment and 30 and 180 days after treatment]

Title

Evaluation of matrix metalloproteinases(MMP) in remodeling of vulvovaginal collagen induced by intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

Description

Time Frame

The evaluation will occur pre-treatment and 30 and 180 days after treatment

Title

Evaluation of visual aspect of vulva after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

Description

Time Frame

The pictures will be taken before and 30 days and 180 days after treatment.]

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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. Absence of vaginal surgical procedure in the last year 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: Active genital infection Active infection of HPV (human papillomavirus) or Herpes users of medications with estrogenic effect (digoxin and other chemicals) Postmenopausal genital bleeding uncontrolled diabetes use of multivitamins with zinc use of copper or hormonal IUDs (intrauterine device) at the time of inclusion presence of genitourinary or rectovaginal fistulas

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ana Maria HM Bianchi-Ferraro, PhD

Phone

+5511995217431

anamariahmb@yahoo.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Zsuzsanna IK Jarmy-di Bella, PhD

Phone

5511983490033

zsuvi@uol.com.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zsuzsanna IK Jarmy-di Bella, PhD

Organizational Affiliation

Professor

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Marair GF Sartori, PhD

Organizational Affiliation

Professor and Head of Gynecology Department

Official's Role

Study Director

Facility Information:

Facility Name

Federal University of Sao Paulo - Unifesp

City

São Paulo

State/Province

ZIP/Postal Code

0-4023- 062

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana Maria HM Bianchi-Ferraro, PhD

Phone

+5511995217431

anamariahmb@yahoo.com.br

First Name & Middle Initial & Last Name & Degree

Zsuzsanna IK Jarmy-di Bella, PhD

Phone

+5511983490033

zsuvi@uol.com.br

First Name & Middle Initial & Last Name & Degree

Marair FG Sartori, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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