<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/NCT03307044</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-17153</org_study_id>
    <secondary_id>NCI-2017-01554</secondary_id>
    <nct_id>NCT03307044</nct_id>
  </id_info>
  <brief_title>Fractional CO2 Laser Therapy for Survivors of Breast Malignancies</brief_title>
  <official_title>Fractional CO2 Laser Therapy for Survivors of Breast Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</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>
      This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works&#xD;
      in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses&#xD;
      intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and&#xD;
      direct controlled thermal damage of vaginal mucosa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To demonstrate the feasibility of fractionated CO2 laser treatments in patients with&#xD;
      breast cancer with vaginal atrophy by determining treatment completion rates and tolerability&#xD;
      of treatment.&#xD;
&#xD;
      II. To demonstrate the efficacy of fractionated CO2 laser treatments in patients with breast&#xD;
      cancer with vaginal atrophy as determined by improvement from baseline to post treatment in&#xD;
      the score of the Vaginal Assessment Scale (VAS).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual&#xD;
      satisfaction scale, Female Sexual Function Index (FSFI), and the Female Sexual Distress Scare&#xD;
      (FSDS).&#xD;
&#xD;
      II. Other symptoms of urogenital atrophy using the Urogenital Distress Inventory (UDI).&#xD;
&#xD;
      III. Overall patient assessment of symptoms by Patient Global Impression of Improvement scale&#xD;
      (PGI-I).&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">May 5, 2022</completion_date>
  <primary_completion_date type="Actual">December 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Vaginal Assessment Scale score</measure>
    <time_frame>Baseline up to 4 weeks</time_frame>
    <description>Using Vaginal Assessment Scale (VAS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient compliance rates</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Compliance rates with treatment will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of laser treatments defined by completion rates and tolerability of treatment</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Will evaluate if laser can be completed and tolerated will be used to summarize demographics and clinical characteristics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other symptoms of urogenital atrophy using the Urogenital Distress Inventory</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemars Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemar?s Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Breast Carcinoma</condition>
  <condition>Cancer Survivor</condition>
  <condition>Cervical Carcinoma</condition>
  <condition>Dyspareunia</condition>
  <condition>Vaginal Dryness</condition>
  <arm_group>
    <arm_group_label>Treatment (fractional CO2 laser therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laser Therapy</intervention_name>
    <description>Undergo fractional CO2 laser therapy</description>
    <arm_group_label>Treatment (fractional CO2 laser therapy)</arm_group_label>
    <other_name>Therapy, Laser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (fractional CO2 laser therapy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status&#xD;
             who have completed surgery, chemotherapy, and radiation and are currently on endocrine&#xD;
             therapy, single agent Herceptin, or observation&#xD;
&#xD;
          -  Symptoms of urogenital atrophy including dyspareunia or vaginal dryness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic breast cancer&#xD;
&#xD;
          -  Vaginal stenosis which would not allow vaginal probe to be placed (based on physician&#xD;
             exam)&#xD;
&#xD;
          -  Active genital infection at the time of enrollment (if present initially, can be&#xD;
             treated and then patient can be re-evaluated for eligibility)&#xD;
&#xD;
          -  Pelvic organ prolapse greater than stage II&#xD;
&#xD;
          -  Prior reconstructive pelvic surgery involving mesh&#xD;
&#xD;
          -  Hormone replacement therapy, vaginal estrogen therapy, DHEA, or biosynthetics within 6&#xD;
             weeks prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allison Quick, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>March 17, 2023</last_update_submitted>
  <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Allison Quick</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Dyspareunia</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/NCT03307044
org study id: OSU-17153
secondary id: NCI-2017-01554
nct id: NCT03307044
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works
      in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses
      intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and
      direct controlled thermal damage of vaginal mucosa.
PRIMARY OBJECTIVES:

      I. To demonstrate the feasibility of fractionated CO2 laser treatments in patients with
      breast cancer with vaginal atrophy by determining treatment completion rates and tolerability
      of treatment.

      II. To demonstrate the efficacy of fractionated CO2 laser treatments in patients with breast
      cancer with vaginal atrophy as determined by improvement from baseline to post treatment in
      the score of the Vaginal Assessment Scale (VAS).

      SECONDARY OBJECTIVES:

      I. Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual
      satisfaction scale, Female Sexual Function Index (FSFI), and the Female Sexual Distress Scare
      (FSDS).

      II. Other symptoms of urogenital atrophy using the Urogenital Distress Inventory (UDI).

      III. Overall patient assessment of symptoms by Patient Global Impression of Improvement scale
      (PGI-I).

      OUTLINE:

      Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.

      After completion of study treatment, patients are followed up at 4 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Vaginal Assessment Scale score
time frame: Baseline up to 4 weeks
description: Using Vaginal Assessment Scale (VAS)
measure: Patient compliance rates
time frame: Up to 4 weeks
description: Compliance rates with treatment will be assessed.
measure: Feasibility of laser treatments defined by completion rates and tolerability of treatment
time frame: Up to 4 weeks
description: Will evaluate if laser can be completed and tolerated will be used to summarize demographics and clinical characteristics.
measure: Other symptoms of urogenital atrophy using the Urogenital Distress Inventory
time frame: Up to 4 weeks
description: Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemars Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary.
measure: Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index, and the Female Sexual Distress Scare
time frame: Up to 4 weeks
description: Descriptive statistics will be used to summarize demographics and clinical characteristics. Will either compare categorical responses from baseline to post treatment using McNemar?s Chi-square test or compare the change in response using a Signed Rank Test. Data will be transformed or a nonparametric test will be conducted if necessary.
arm group label: Treatment (fractional CO2 laser therapy)
arm group type: Experimental
description: Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.
intervention type: Procedure
intervention name: Laser Therapy
description: Undergo fractional CO2 laser therapy
arm group label: Treatment (fractional CO2 laser therapy)
other name: Therapy, Laser
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Treatment (fractional CO2 laser therapy)
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Allison Quick, MD
role: Principal Investigator
affiliation: Ohio State University Comprehensive Cancer Center
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Allison Quick
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Dyspareunia
sharing ipd: No