<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03833726</url>
  </required_header>
  <id_info>
    <org_study_id>CAAP CA</org_study_id>
    <nct_id>NCT03833726</nct_id>
  </id_info>
  <brief_title>Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment</brief_title>
  <acronym>LEDCA</acronym>
  <official_title>Light Emitting Diode for the Treatment of Genitourinary Syndrome of Menopause Associated With Hormonal Therapy for Treating Breast Cancer: Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro de Atenção ao Assoalho Pélvico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro de Atenção ao Assoalho Pélvico</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone&#xD;
      therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate&#xD;
      a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation,&#xD;
      pruritus, pain or discomfort in intercourse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Genitourinary Menopause Syndrome (MMS) affects up to 70% of in treatment breast cancer&#xD;
      patients. Symptoms are due to a decrease in hormone levels or block to circulating hormones&#xD;
      and induce functional changes in the vagina cutting in quality of life and impacting sexual&#xD;
      function.&#xD;
&#xD;
      This is a randomized, double blind trial in a sample of 74 individuals that will be performed&#xD;
      at an specialized Pelvic Floor Care Center (CAAP) in Brazil. Will be included women age&#xD;
      between 18 and 65 years, in adjuvant hormone therapy, with clinical signs and symptoms of&#xD;
      vulvovaginal atrophy syndrome and cytologic evidence of atrophy, (pH &lt;5.0 and vaginal&#xD;
      cytology with predominance of superficial cells).&#xD;
&#xD;
      Will be excluded from the study the patients in hormonal replacement for less than 6 months,&#xD;
      diagnosis of vaginal infection, pregnant women, difficulty understanding the proposed&#xD;
      instruments and patients with chronic neurological degenerative diseases.&#xD;
&#xD;
      Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days&#xD;
      interval between them compared with sham procedure, and both groups will perform five&#xD;
      sessions of kinesiotherapy sessions.&#xD;
&#xD;
      Maturation vaginal index will be checked before and after all treatment and self-&#xD;
      administered questionnaires will be performed before each session with Female Sexual Function&#xD;
      Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7),&#xD;
      International Consultation on Incontinence Questionnaire - Short Form, (ICIQ-SF), Functional&#xD;
      Assessment Of Cancer Therapy - Breast Cancer (FACT-B).&#xD;
&#xD;
      At the end of treatment, the visual analog scale and Likert scale will be used to measure the&#xD;
      individual's satisfaction&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study will be conducted women diagnosed with Genitourinary Syndrome of Menopause treated with kinesiotherapy, divided in two groups: LED treatment or LED Sham.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>The participant will be randomly divided between LED group or LED Sham procedure that will consist of turned off device and heated gel and both patients and physiotherapists of kinesiotherapy phase wont be aware with group the participant is allocated.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Vaginal maturation index</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>Cytological vaginal will be collected at 1/3 lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Female Sexual Function Index (FSFI) - Female Version (QS-F)</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>Measure of quality of sex life. Full Scale Score Range 2-36</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vaginal pH</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>pH indicator tape</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life by FACT B</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary symptoms</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>International Consultation on Incontinence Questionnaire - Short Form (ICIQ Questionary Short Form)-Scoring scale: 0-21 (lower values means better quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>Stratification between 0 and 10 (few symptoms to severe symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Female Genital Self-Image Scale - 7 (FGSIS-7)</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>Measure of quality of sex life. Scores between 7-28 (higher scores indicate better self-image)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likert scale</measure>
    <time_frame>Change from finished treatment and 3 months after</time_frame>
    <description>Satisfaction with the treatment measured between 1 and 5 ( not at all happy with the treatment -very happy with the treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Quotients Female Version (QS-F)</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>Change from baseline at 3 months</time_frame>
    <description>Short Form health survey 36 questionnaire, (0-100) - lower values means worse quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Atrophy;Vaginal</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>LED group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who will submitted to active procedure with LED. Both groups will be submitted to kinesiotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants who will submitted to sham procedure with heated gel. Both groups will be submitted to kinesiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Experimental: LED group</intervention_name>
    <description>5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.</description>
    <arm_group_label>LED group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Comparator: Control</intervention_name>
    <description>5 Sessions of 8 minute with device off and heated gel, 7 days apart.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 anos&#xD;
&#xD;
          -  Pathological proven Breast Cancer diagnosis&#xD;
&#xD;
          -  Stage 0-III by American Joint Committee on Cancer (AJCC) and International Union&#xD;
             Against Cancer (UICC) of Classification of Malignant Tumours, TNM (Acronym for&#xD;
             Tumor-Node-Metastasis) 8ª edition&#xD;
&#xD;
          -  Genitourinary Syndrome of Menopause confirmed through patient-reported symptoms and&#xD;
             gynecological examination (of external structures, introitus, and vaginal mucosa)&#xD;
&#xD;
          -  Vaginal pH &gt;5,0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hormone replacement less than 6 months&#xD;
&#xD;
          -  Diagnosis of vaginal infection&#xD;
&#xD;
          -  Difficulty in understanding the proposed instruments&#xD;
&#xD;
          -  Patients with chronic neurological degenerative diseases that preclude to be on&#xD;
             position&#xD;
&#xD;
          -  Metastatic disease&#xD;
&#xD;
          -  Any vaginal photodynamic treatment less than 3 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patríca V Lordelo, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Centro de Atenção Pélvica- CAAP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrícia V Lordêlo, PhD</last_name>
    <phone>+5571988592400</phone>
    <email>pvslordelo@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniela B de Oliveira, MD</last_name>
    <phone>+55 71 988469597</phone>
    <email>danielagbarros@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centro de Atenção ao Assoalho Pelvico</name>
      <address>
        <city>Salvador</city>
        <state>Ba</state>
        <zip>40.290-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia V Lordelo, Phd</last_name>
      <phone>+5571988592400</phone>
      <email>pvslordelo@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://evs.nci.nih.gov/ftp1/CTCAE</url>
    <description>NCI Toxicity Scale</description>
  </link>
  <reference>
    <citation>Lester J, Pahouja G, Andersen B, Lustberg M. Atrophic vaginitis in breast cancer survivors: a difficult survivorship issue. J Pers Med. 2015 Mar 25;5(2):50-66. doi: 10.3390/jpm5020050.</citation>
    <PMID>25815692</PMID>
  </reference>
  <reference>
    <citation>Kyvernitakis I, Ziller V, Hars O, Bauer M, Kalder M, Hadji P. Prevalence of menopausal symptoms and their influence on adherence in women with breast cancer. Climacteric. 2014 Jun;17(3):252-9. doi: 10.3109/13697137.2013.819327. Epub 2013 Aug 25.</citation>
    <PMID>23805799</PMID>
  </reference>
  <reference>
    <citation>Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Maturitas. 2014 Nov;79(3):349-54. doi: 10.1016/j.maturitas.2014.07.013. Epub 2014 Aug 19.</citation>
    <PMID>25179577</PMID>
  </reference>
  <reference>
    <citation>Nilsson K, Risberg B, Heimer G. The vaginal epithelium in the postmenopause--cytology, histology and pH as methods of assessment. Maturitas. 1995 Jan;21(1):51-6. doi: 10.1016/0378-5122(94)00863-3.</citation>
    <PMID>7731384</PMID>
  </reference>
  <reference>
    <citation>Moreno AC, Sikka SK, Thacker HL. Genitourinary syndrome of menopause in breast cancer survivors:Treatments are available. Cleve Clin J Med. 2018 Oct;85(10):760-766. doi: 10.3949/ccjm.85a.17108. Erratum In: Cleve Clin J Med. 2018 Nov;85(11):860.</citation>
    <PMID>30289755</PMID>
  </reference>
  <reference>
    <citation>Arunkalaivanan A, Kaur H, Onuma O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: a critical appraisal of evidence. Int Urogynecol J. 2017 May;28(5):681-685. doi: 10.1007/s00192-017-3282-y. Epub 2017 Feb 2.</citation>
    <PMID>28154914</PMID>
  </reference>
  <reference>
    <citation>Yaralizadeh M, Abedi P, Najar S, Namjoyan F, Saki A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial. Maturitas. 2016 Feb;84:75-80. doi: 10.1016/j.maturitas.2015.11.005. Epub 2015 Nov 12.</citation>
    <PMID>26617271</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaginal Atrophy</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Hormonal Therapy</keyword>
  <keyword>Photodynamic Therapy</keyword>
  <keyword>Light Emitting Diode</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833726
org study id: CAAP CA
nct id: NCT03833726
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study will be conducted women diagnosed with Genitourinary Syndrome of Menopause treated with kinesiotherapy, divided in two groups: LED treatment or LED Sham.
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: The participant will be randomly divided between LED group or LED Sham procedure that will consist of turned off device and heated gel and both patients and physiotherapists of kinesiotherapy phase wont be aware with group the participant is allocated.
measure: Vaginal maturation index
time frame: Change from baseline at 3 months
description: Cytological vaginal will be collected at 1/3 lower lateral vaginal wall and quantified superficial, intermediate and basal cells to calculate vaginal maturation index
measure: Female Sexual Function Index (FSFI) - Female Version (QS-F)
time frame: Change from baseline at 3 months
description: Measure of quality of sex life. Full Scale Score Range 2-36
measure: Vaginal pH
time frame: Change from baseline at 3 months
description: pH indicator tape
measure: Quality of life by FACT B
time frame: Change from baseline at 3 months
description: 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
measure: Urinary symptoms
time frame: Change from baseline at 3 months
description: International Consultation on Incontinence Questionnaire - Short Form (ICIQ Questionary Short Form)-Scoring scale: 0-21 (lower values means better quality of life)
measure: Visual analog scale
time frame: Change from baseline at 3 months
description: Stratification between 0 and 10 (few symptoms to severe symptoms)
measure: Female Genital Self-Image Scale - 7 (FGSIS-7)
time frame: Change from baseline at 3 months
description: Measure of quality of sex life. Scores between 7-28 (higher scores indicate better self-image)
measure: Likert scale
time frame: Change from finished treatment and 3 months after
description: Satisfaction with the treatment measured between 1 and 5 ( not at all happy with the treatment -very happy with the treatment)
measure: Sexual Quotients Female Version (QS-F)
time frame: Change from baseline at 3 months
description: 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
measure: SF-36
time frame: Change from baseline at 3 months
description: Short Form health survey 36 questionnaire, (0-100) - lower values means worse quality of life
arm group label: LED group
arm group type: Experimental
description: Participants who will submitted to active procedure with LED. Both groups will be submitted to kinesiotherapy.
arm group label: Control group
arm group type: Sham Comparator
description: Participants who will submitted to sham procedure with heated gel. Both groups will be submitted to kinesiotherapy.
intervention type: Procedure
intervention name: Experimental: LED group
description: 5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.
arm group label: LED group
intervention type: Procedure
intervention name: Sham Comparator: Control
description: 5 Sessions of 8 minute with device off and heated gel, 7 days apart.
arm group label: Control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Patríca V Lordelo, PhD
role: Study Chair
affiliation: Centro de Atenção Pélvica- CAAP
last name: Patrícia V Lordêlo, PhD
phone: +5571988592400
email: pvslordelo@hotmail.com
last name: Daniela B de Oliveira, MD
phone: +55 71 988469597
email: danielagbarros@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
url: http://evs.nci.nih.gov/ftp1/CTCAE
description: NCI Toxicity Scale
citation: Lester J, Pahouja G, Andersen B, Lustberg M. Atrophic vaginitis in breast cancer survivors: a difficult survivorship issue. J Pers Med. 2015 Mar 25;5(2):50-66. doi: 10.3390/jpm5020050.
PMID: 25815692
citation: Kyvernitakis I, Ziller V, Hars O, Bauer M, Kalder M, Hadji P. Prevalence of menopausal symptoms and their influence on adherence in women with breast cancer. Climacteric. 2014 Jun;17(3):252-9. doi: 10.3109/13697137.2013.819327. Epub 2013 Aug 25.
PMID: 23805799
citation: Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Maturitas. 2014 Nov;79(3):349-54. doi: 10.1016/j.maturitas.2014.07.013. Epub 2014 Aug 19.
PMID: 25179577
citation: Nilsson K, Risberg B, Heimer G. The vaginal epithelium in the postmenopause--cytology, histology and pH as methods of assessment. Maturitas. 1995 Jan;21(1):51-6. doi: 10.1016/0378-5122(94)00863-3.
PMID: 7731384
citation: Moreno AC, Sikka SK, Thacker HL. Genitourinary syndrome of menopause in breast cancer survivors:Treatments are available. Cleve Clin J Med. 2018 Oct;85(10):760-766. doi: 10.3949/ccjm.85a.17108. Erratum In: Cleve Clin J Med. 2018 Nov;85(11):860.
PMID: 30289755
citation: Arunkalaivanan A, Kaur H, Onuma O. Laser therapy as a treatment modality for genitourinary syndrome of menopause: a critical appraisal of evidence. Int Urogynecol J. 2017 May;28(5):681-685. doi: 10.1007/s00192-017-3282-y. Epub 2017 Feb 2.
PMID: 28154914
citation: Yaralizadeh M, Abedi P, Najar S, Namjoyan F, Saki A. Effect of Foeniculum vulgare (fennel) vaginal cream on vaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled trial. Maturitas. 2016 Feb;84:75-80. doi: 10.1016/j.maturitas.2015.11.005. Epub 2015 Nov 12.
PMID: 26617271
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Atrophy