<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/NCT03816735</url>
  </required_header>
  <id_info>
    <org_study_id>30-225 ex 17/18</org_study_id>
    <nct_id>NCT03816735</nct_id>
  </id_info>
  <brief_title>Laser vs Hyaluronic Acid for GSM in Breast Cancer</brief_title>
  <official_title>Erbium:Yag Laser vs Hyaluronic Acid Suppository for GSM in Breast Cancer (BC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      All women from the outpatient department with a history of BC and GSM (genitourinary symptoms&#xD;
      of menopause) symptoms will be invited to participate.&#xD;
&#xD;
      After informed consent patients are either randomized to intravaginal laser or hyaluronic&#xD;
      acid suppository treatment intravaginally, respectively. Laser treatment will be performed&#xD;
      twice, at baseline and after 1 month. The intravaginal hyaluronic acid suppository therapy&#xD;
      will be applied daily during the first 10 days and then every third day until the three&#xD;
      months follow-up.&#xD;
&#xD;
      At baseline and three months follow-up the following questionnaires will be filled out (VAS,&#xD;
      (PGI-I, PGI-S, Female Sexual health questionnaire (EORTC), Baessler questionnaire, EORTC&#xD;
      quality of life questionnaire, ZUF-8).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Device I- Laser The laser device is the Juliet feminine laser to treat women with SUI (Stress&#xD;
      Urinary Incontinence), GSM and vaginal laxity. Asclepion' s headquarters are located in&#xD;
      &quot;Asclepion Laser Technologies GmbH - Brüsseler Str. 10 - 07747 Jena - Germany&quot;.&#xD;
&#xD;
      Device II- Suppository The second device is a vaginal suppository called &quot;Cikatridina&quot;&#xD;
      manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich&#xD;
      GmbH's headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Randomized open study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>genitorurinary symptoms of menopause (GSM) determined by vaginal health index score</measure>
    <time_frame>3 months</time_frame>
    <description>Vaginal Health Score Index (VHIS) evaluates the appearance of the vaginal mucosa (elasticity, pH, vaginal discharge, mucosal integrity and moisture) on a scale from 1 to 5 each. The lower the score the worse the symptom.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms severity- visual analogue scale</measure>
    <time_frame>3 months</time_frame>
    <description>A visual analogue scale (VAS) is used for assessment for the subjective bother of GSM. The lower the score the less bothering are the symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment discomfort / pain; assessed by visual analogue scale</measure>
    <time_frame>3 months</time_frame>
    <description>At the end of each laser treatment session or at 3 months for the vaginal suppository group patients are asked to indicate the degree of discomfort or pain during laser therapy/vaginal insertion of the suppositories on a scale ranging from 0 (no discomfort/pain) to 10 (worst possible discomfort/pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Improvement</measure>
    <time_frame>3 months</time_frame>
    <description>The Patient Global Impression of Improvement (PGI-I) are robust and valid instruments to assess disease severity, bother and improvement after treatment in women. It ranges from very much improved to a lot worse on 7 likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Severity</measure>
    <time_frame>3 months</time_frame>
    <description>The Patient Global Impression of Severity (PGI-S) is a global index that may be used to rate the severity of a specific condition (a single-state scale). The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment. The patient can choose from 4 answers including none, mild, moderate and severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Female Sexual health</measure>
    <time_frame>3 months</time_frame>
    <description>The Female Sexual health is assessed with the European Organisation for Research and Treatment of Cancer (EORTC) sexual health questionnaire and is a validated questionnaire which assesses physical, psychological, and social aspects of sexuality of cancer survivors. It is a 22 item questionnaire.The higher the score the better is the sexual function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pelvic floor symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>A validated self-administered pelvic floor questionnaire (Baessler) will be used to assess urogentinal symptoms. Questions regarding bladder (15), bowel (12), and sexual function (10), and pelvic organ prolapse symptoms (five) are grouped according to the physiological functions of the pelvic floor: bladder function, bowel function, prolapse symptoms, and sexual function domains. Quality of life measures and bothersomeness ratings were integrated into the four domains. Frequency, severity, and bothersomeness of pelvic floor symptoms are assessed using a four-point scoring system for most items in the questionnaire, apart from defecation frequency, bowel consistency, sufficient lubrication, and the reason for sexual abstinence. The lower the score the less pelvic floor symptoms the patients have.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with treatment/ inpatient management</measure>
    <time_frame>3 months</time_frame>
    <description>&quot;Fragebogen zur Patientenzufriedenheit - ZUF8&quot;. The questionnaire, the German version of the original &quot;Client Satisfaction Questionnaire-CSQ8&quot;, is a validated tool for measuring global patient satisfaction at the end of inpatient treatment. The Zuf-8 is an 8-items questionnaire to assess satisfaction in patients undergoing inpatient treatment. At 3 months treatment satisfaction will be assessed using an adopted version of the questionnaire. The lower the score the higher is the patient satiscation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discontinuation rate</measure>
    <time_frame>3 months</time_frame>
    <description>Number of patients who discontinue treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspareunia rate</measure>
    <time_frame>3 months</time_frame>
    <description>evaluated by a single item of the Baessler questionnaire. The rate will be given in number and percent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: EORTC quality of life questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Determined by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire. The questionnaire is a 47 item questionnaire and assess quality of life. The lower the score the better the quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Urogenital Disease</condition>
  <arm_group>
    <arm_group_label>hyaluronic acid suppository therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women receive a vaginal suppository called &quot;Cikatridina&quot; manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich GmbH's headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria. The suppositories contain ontain hyaluronic acid, tea tree oil, tigergras extract, and aloe vera.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Juliet feminine laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The fractional microablative laser with 2940 nm wavelength has a high degree of absorption in water and selectively stimulates the synthesis of sub-mucosal collagen. The erbium-doped yttrium-aluminum-garnet (Er:YAG) laser has been successfully used in the field of plastic skin rejuvenation and reconstruction. The procedure is based on photothermic treatment of connective tissue: It has been established in animal and human studies that it affects collagen remodeling resulting in tightening of the supportive tissue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cikatridina</intervention_name>
    <description>Women are asked to insert the suppositories according to the manufacturer's protocol.</description>
    <arm_group_label>hyaluronic acid suppository therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Juliet Feminine Laser</intervention_name>
    <description>Women will receive the laser treatment twice during the study period.</description>
    <arm_group_label>Juliet feminine laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  genital symptoms of dryness/ burning/ irritation&#xD;
&#xD;
               -  and/ or lack of lubrication during sexual intercourse/ sexual discomfort or pain&#xD;
&#xD;
               -  and/or symptoms of urgency and dysuria or recurrent urinary tract infection&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
          -  History of BC and/ or DCIS&#xD;
&#xD;
          -  Completed locoregional therapy&#xD;
&#xD;
          -  Current antihormonal therapy for BC possible&#xD;
&#xD;
          -  Intravaginal treatment with creams/ suppositories other than study medicationshould be&#xD;
             ceased during the trial&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Current or past genitourinary malignancy&#xD;
&#xD;
          -  Abnormal PAP smear&#xD;
&#xD;
          -  Current genitourinary tract infection&#xD;
&#xD;
          -  Abnormal uterine bleeding&#xD;
&#xD;
          -  photosensitive medication&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Daniela Gold, MD PhD</last_name>
    <phone>004331638512201</phone>
    <email>daniela.gold@medunigraz.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Obstetrics, Medical University Graz</name>
      <address>
        <city>Graz</city>
        <zip>8045</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniela Gold (Ulrich), MD, PhD</last_name>
      <phone>+4331638512201</phone>
      <email>daniela.gold@medunigraz.at</email>
    </contact>
    <investigator>
      <last_name>Daniela Gold, M.D. PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karl Tamussino, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gerda Trutnovsky, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urogenital Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03816735
org study id: 30-225 ex 17/18
nct id: NCT03816735
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
All women from the outpatient department with a history of BC and GSM (genitourinary symptoms
      of menopause) symptoms will be invited to participate.

      After informed consent patients are either randomized to intravaginal laser or hyaluronic
      acid suppository treatment intravaginally, respectively. Laser treatment will be performed
      twice, at baseline and after 1 month. The intravaginal hyaluronic acid suppository therapy
      will be applied daily during the first 10 days and then every third day until the three
      months follow-up.

      At baseline and three months follow-up the following questionnaires will be filled out (VAS,
      (PGI-I, PGI-S, Female Sexual health questionnaire (EORTC), Baessler questionnaire, EORTC
      quality of life questionnaire, ZUF-8).
Device I- Laser The laser device is the Juliet feminine laser to treat women with SUI (Stress
      Urinary Incontinence), GSM and vaginal laxity. Asclepion' s headquarters are located in
      "Asclepion Laser Technologies GmbH - Brüsseler Str. 10 - 07747 Jena - Germany".

      Device II- Suppository The second device is a vaginal suppository called "Cikatridina"
      manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich
      GmbH's headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized open study
primary purpose: Treatment
masking: None (Open Label)
measure: genitorurinary symptoms of menopause (GSM) determined by vaginal health index score
time frame: 3 months
description: Vaginal Health Score Index (VHIS) evaluates the appearance of the vaginal mucosa (elasticity, pH, vaginal discharge, mucosal integrity and moisture) on a scale from 1 to 5 each. The lower the score the worse the symptom.
measure: Symptoms severity- visual analogue scale
time frame: 3 months
description: A visual analogue scale (VAS) is used for assessment for the subjective bother of GSM. The lower the score the less bothering are the symptoms.
measure: Treatment discomfort / pain; assessed by visual analogue scale
time frame: 3 months
description: At the end of each laser treatment session or at 3 months for the vaginal suppository group patients are asked to indicate the degree of discomfort or pain during laser therapy/vaginal insertion of the suppositories on a scale ranging from 0 (no discomfort/pain) to 10 (worst possible discomfort/pain)
measure: Patient Global Impression of Improvement
time frame: 3 months
description: The Patient Global Impression of Improvement (PGI-I) are robust and valid instruments to assess disease severity, bother and improvement after treatment in women. It ranges from very much improved to a lot worse on 7 likert scale.
measure: Patient Global Impression of Severity
time frame: 3 months
description: The Patient Global Impression of Severity (PGI-S) is a global index that may be used to rate the severity of a specific condition (a single-state scale). The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment. The patient can choose from 4 answers including none, mild, moderate and severe.
measure: Female Sexual health
time frame: 3 months
description: The Female Sexual health is assessed with the European Organisation for Research and Treatment of Cancer (EORTC) sexual health questionnaire and is a validated questionnaire which assesses physical, psychological, and social aspects of sexuality of cancer survivors. It is a 22 item questionnaire.The higher the score the better is the sexual function.
measure: pelvic floor symptoms
time frame: 3 months
description: A validated self-administered pelvic floor questionnaire (Baessler) will be used to assess urogentinal symptoms. Questions regarding bladder (15), bowel (12), and sexual function (10), and pelvic organ prolapse symptoms (five) are grouped according to the physiological functions of the pelvic floor: bladder function, bowel function, prolapse symptoms, and sexual function domains. Quality of life measures and bothersomeness ratings were integrated into the four domains. Frequency, severity, and bothersomeness of pelvic floor symptoms are assessed using a four-point scoring system for most items in the questionnaire, apart from defecation frequency, bowel consistency, sufficient lubrication, and the reason for sexual abstinence. The lower the score the less pelvic floor symptoms the patients have.
measure: Patient satisfaction with treatment/ inpatient management
time frame: 3 months
description: "Fragebogen zur Patientenzufriedenheit - ZUF8". The questionnaire, the German version of the original "Client Satisfaction Questionnaire-CSQ8", is a validated tool for measuring global patient satisfaction at the end of inpatient treatment. The Zuf-8 is an 8-items questionnaire to assess satisfaction in patients undergoing inpatient treatment. At 3 months treatment satisfaction will be assessed using an adopted version of the questionnaire. The lower the score the higher is the patient satiscation.
measure: Discontinuation rate
time frame: 3 months
description: Number of patients who discontinue treatment
measure: Dyspareunia rate
time frame: 3 months
description: evaluated by a single item of the Baessler questionnaire. The rate will be given in number and percent.
measure: Quality of life: EORTC quality of life questionnaire
time frame: 3 months
description: Determined by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire. The questionnaire is a 47 item questionnaire and assess quality of life. The lower the score the better the quality of life.
arm group label: hyaluronic acid suppository therapy
arm group type: Active Comparator
description: Women receive a vaginal suppository called "Cikatridina" manufactured by the company Angelini to treat women with GSM. Angelini Pharma Österreich GmbH's headquarters are located in Brigittenauer Lände 50-54, 1200 Wien, Austria. The suppositories contain ontain hyaluronic acid, tea tree oil, tigergras extract, and aloe vera.
arm group label: Juliet feminine laser
arm group type: Active Comparator
description: The fractional microablative laser with 2940 nm wavelength has a high degree of absorption in water and selectively stimulates the synthesis of sub-mucosal collagen. The erbium-doped yttrium-aluminum-garnet (Er:YAG) laser has been successfully used in the field of plastic skin rejuvenation and reconstruction. The procedure is based on photothermic treatment of connective tissue: It has been established in animal and human studies that it affects collagen remodeling resulting in tightening of the supportive tissue.
intervention type: Device
intervention name: Cikatridina
description: Women are asked to insert the suppositories according to the manufacturer's protocol.
arm group label: hyaluronic acid suppository therapy
intervention type: Device
intervention name: Juliet Feminine Laser
description: Women will receive the laser treatment twice during the study period.
arm group label: Juliet feminine laser
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniela Gold, MD PhD
phone: 004331638512201
email: daniela.gold@medunigraz.at
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Austria
responsible party type: Sponsor
mesh term: Urogenital Diseases
sharing ipd: No