Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment (LEDCA)

December 4, 2023 updated by: Centro de Atenção ao Assoalho Pélvico

Light Emitting Diode for the Treatment of Genitourinary Syndrome of Menopause Associated With Hormonal Therapy for Treating Breast Cancer: Randomized Controlled Clinical Trial

Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Genitourinary Menopause Syndrome (MMS) affects up to 70% of in treatment breast cancer patients. Symptoms are due to a decrease in hormone levels or block to circulating hormones and induce functional changes in the vagina cutting in quality of life and impacting sexual function.

This is a randomized, double blind trial in a sample of 74 individuals that will be performed at an specialized Pelvic Floor Care Center (CAAP) in Brazil. Will be included women age between 18 and 65 years, in adjuvant hormone therapy, with clinical signs and symptoms of vulvovaginal atrophy syndrome and cytologic evidence of atrophy, (pH <5.0 and vaginal cytology with predominance of superficial cells).

Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, pregnant women, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases.

Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them compared with sham procedure, and both groups will perform five sessions of kinesiotherapy sessions.

Maturation vaginal index will be checked before and after all treatment and self- administered questionnaires will be performed before each session with Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7), International Consultation on Incontinence Questionnaire - Short Form, (ICIQ-SF), Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B).

At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ba
      • Salvador, Ba, Brazil, 40.290-000
        • Centro de Atenção ao assoalho pélvico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-65 anos
  • Pathological proven Breast Cancer diagnosis
  • Stage 0-III by American Joint Committee on Cancer (AJCC) and International Union Against Cancer (UICC) of Classification of Malignant Tumours, TNM (Acronym for Tumor-Node-Metastasis) 8ª edition
  • Genitourinary Syndrome of Menopause confirmed through patient-reported symptoms and gynecological examination (of external structures, introitus, and vaginal mucosa)
  • Vaginal pH >5,0

Exclusion Criteria:

  • Hormone replacement less than 6 months
  • Diagnosis of vaginal infection
  • Difficulty in understanding the proposed instruments
  • Patients with chronic neurological degenerative diseases that preclude to be on position
  • Metastatic disease
  • Any vaginal photodynamic treatment less than 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LED group
Participants who will submitted to active procedure with LED. Both groups will be submitted to kinesiotherapy.
Procedure: Experimental: LED group
5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.
Sham Comparator: Control group
Participants who will submitted to sham procedure with heated gel. Both groups will be submitted to kinesiotherapy.
Procedure: Sham Comparator: Control
5 Sessions of 8 minute with device off and heated gel, 7 days apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal maturation index
Time Frame: Change from baseline at 3 months
Cytological vaginal will be collected at 1/3 lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index
Change from baseline at 3 months
Female Sexual Function Index (FSFI) - Female Version (QS-F)
Time Frame: Change from baseline at 3 months
Measure of quality of sex life. Full Scale Score Range 2-36
Change from baseline at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal pH
Time Frame: Change from baseline at 3 months
pH indicator tape
Change from baseline at 3 months
Quality of life by FACT B
Time Frame: Change from baseline at 3 months
Functional Assessment of Chronic Therapy- Breast (FACT B) Questionary validated to Portuguese to measure quality of life in breast cancer patients (Total score and Subscale). Graduated 0-128 (lower values means worse quality of life). Physical Wellbeing (PWB) 0-28; Social/Family Wellbeing (SWB) 0-28; Emotional Wellbeing (EWB) 0-24; Funtional Wellbeing (FWB) 0-28; Breast Cancer Subscale (BCS) 0-40. Total Score do not include Arm Subscale (ARM) 0-20
Change from baseline at 3 months
Urinary symptoms
Time Frame: Change from baseline at 3 months
International Consultation on Incontinence Questionnaire - Short Form (ICIQ Questionary Short Form)-Scoring scale: 0-21 (lower values means better quality of life)
Change from baseline at 3 months
Visual analog scale
Time Frame: Change from baseline at 3 months
Stratification between 0 and 10 (few symptoms to severe symptoms)
Change from baseline at 3 months
Female Genital Self-Image Scale - 7 (FGSIS-7)
Time Frame: Change from baseline at 3 months
Measure of quality of sex life. Scores between 7-28 (higher scores indicate better self-image)
Change from baseline at 3 months
Likert scale
Time Frame: Change from finished treatment and 3 months after
Satisfaction with the treatment measured between 1 and 5 ( not at all happy with the treatment -very happy with the treatment)
Change from finished treatment and 3 months after
Sexual Quotients Female Version (QS-F)
Time Frame: Change from baseline at 3 months
Female sex life domain. Scores between 0-100 (higher scores indicate better sex life) Scores between 82-100 score: excellent, 62-80 score: regular, 42-60 score: unfavorable, 22-40 score: regular, 0-20 score: bad
Change from baseline at 3 months
SF-36
Time Frame: Change from baseline at 3 months
Short Form health survey 36 questionnaire, (0-100) - lower values means worse quality of life
Change from baseline at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Atenção ao Assoalho Pélvico

Investigators

  • Study Chair: Patríca V Lordelo, PhD, Centro de Atenção Pélvica- CAAP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2019

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

December 16, 2018

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 7, 2019

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAP CA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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