<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/NCT01693731</url>
  </required_header>
  <id_info>
    <org_study_id>5K23DEO21779</org_study_id>
    <secondary_id>5K23DE021779</secondary_id>
    <secondary_id>HUM00048451</secondary_id>
    <nct_id>NCT01693731</nct_id>
  </id_info>
  <brief_title>Oral Health in Breast Cancer Survivors on Aromatase Inhibitors</brief_title>
  <official_title>Oral Health in Breast Cancer Survivors on Aromatase Inhibitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how aromatase inhibitors (AIs) such as Arimidex,&#xD;
      Aromasin or Femara affect a woman's oral health and oral health related quality of life.&#xD;
      Patients, dental professionals and medical oncologists will benefit from a greater&#xD;
      understanding of the best oral care follow up practices of breast cancer survivors using&#xD;
      aromatase inhibitors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES:&#xD;
&#xD;
      Primary&#xD;
&#xD;
      This cross-sectional prevalence study seeks to investigate the incidence and severity of oral&#xD;
      health changes, specifically of periodontal conditions, among breast cancer survivors and the&#xD;
      ways in which these outcomes affect their quality of life.&#xD;
&#xD;
      Secondary&#xD;
&#xD;
        -  To determine the prevalence and severity of oral conditions in postmenopausal women with&#xD;
           early stage breast cancer using adjuvant AI therapy as compared to postmenopausal women&#xD;
           not using adjuvant AI therapy.&#xD;
&#xD;
        -  To determine if adjuvant AI therapy use is associated with greater alveolar bone loss or&#xD;
           increased levels of bone turnover biomarkers in postmenopausal women with cancer&#xD;
           undergoing adjuvant AI therapy compared to postmenopausal women not receiving AI&#xD;
           therapy.&#xD;
&#xD;
        -  To determine the oral health-related quality of life among postmenopausal women with&#xD;
           early stage breast cancer who are receiving adjuvant AI therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Periodontal diseases</measure>
    <time_frame>At the time of study visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alveolar bone loss using salivary and serum-derived bone markers.</measure>
    <time_frame>At the time of study visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral Health Related Quality of Life (OHRQoL) assessed via questionnaire</measure>
    <time_frame>At the time of study visit</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Periodontal Disease</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Aromatase Inhibitor</arm_group_label>
    <description>Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Treatment</arm_group_label>
    <description>Healthy volunteer postmenopausal women not taking Aromatase Inhibitors</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Each patient will have 5ml of blood collected at the visit. Saliva, and urine will also be&#xD;
      collected at the study visit.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will have a sample of 300 postmenopausal women; 150 healthy women and 150 with&#xD;
        early breast cancer using Aromatase Inhibitors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Postmenopausal as defined by NCCN (any of the following)&#xD;
&#xD;
          -  Prior bilateral oophorectomy&#xD;
&#xD;
          -  Age equal to or greater then 60 years of age&#xD;
&#xD;
          -  Age less then 60 and amenorrheic for 12 or more months in the absence of chemotherapy,&#xD;
             tamoxifen, toremifen or ovarian suppression and FSH and estradiol in the&#xD;
             postmenopausal range&#xD;
&#xD;
          -  If taking tamoxifen or toremifen and age less then 60y, then FSH and plasma estradiol&#xD;
             level in postmenopausal ranges&#xD;
&#xD;
        Informed consent- Individuals capable of consenting and self administering the survey&#xD;
        instrument Dentate- At least 15 teeth present.&#xD;
&#xD;
        AI users:&#xD;
&#xD;
          -  Diagnosis of BCa- Histologic confirmed diagnosis of BCa: Stage 0, I, II, or III with&#xD;
             no evidence of metastatic disease.&#xD;
&#xD;
          -  Treatment- AI as clinically indicated (AI may be anastrozole, exemestane or letrozole)&#xD;
             &gt; 1 month. Subjects may have had prior tamoxifen or raloxifene. Subjects may have had&#xD;
             chemotherapy and/or radiation therapy. Must be within the first year of consecutive AI&#xD;
             therapy. If a subject started AI, discontinued, then restarted, they will be accepted&#xD;
             into the study.&#xD;
&#xD;
        Controls:&#xD;
&#xD;
          -  No Diagnosis of cancer.- Patients must not have a diagnosis of any cancer (Not&#xD;
             including a history of localized thyroid or skin cancer).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Medical history&#xD;
&#xD;
          -  Metastatic BCa (AI treated group: fully resected locally recurrent disease is&#xD;
             permitted if the patient has been rendered without evidence of disease).&#xD;
&#xD;
          -  Significant psychiatric illness/social situations that would preclude completion of&#xD;
             questionnaire.&#xD;
&#xD;
        Medications&#xD;
&#xD;
          -  Chronic medications known to affect the periodontal status (calcium antagonist,&#xD;
             anti-convulsives, immunosuppressives (&gt; prednisone 7.5mg daily). NSAIDS and&#xD;
             bisphosphonates are permitted.&#xD;
&#xD;
          -  Premedication- Conditions that require antibiotic therapy will be evaluated on a&#xD;
             case-by-case basis. (Patients taking prophylaxis for joint replacements will not be&#xD;
             excluded.)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>L. Susan Taichman, RDH MPH PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michigan Center For Oral Health Research (MCOHR)</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>May 18, 2015</last_update_submitted>
  <last_update_submitted_qc>May 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Linda Susan Taichman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Periodontal Diseases</keyword>
  <keyword>Aromatase Inhibitors</keyword>
  <keyword>Oral Health Related Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</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/NCT01693731
org study id: 5K23DEO21779
secondary id: 5K23DE021779
secondary id: HUM00048451
nct id: NCT01693731
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine how aromatase inhibitors (AIs) such as Arimidex,
      Aromasin or Femara affect a woman's oral health and oral health related quality of life.
      Patients, dental professionals and medical oncologists will benefit from a greater
      understanding of the best oral care follow up practices of breast cancer survivors using
      aromatase inhibitors.
OBJECTIVES:

      Primary

      This cross-sectional prevalence study seeks to investigate the incidence and severity of oral
      health changes, specifically of periodontal conditions, among breast cancer survivors and the
      ways in which these outcomes affect their quality of life.

      Secondary

        -  To determine the prevalence and severity of oral conditions in postmenopausal women with
           early stage breast cancer using adjuvant AI therapy as compared to postmenopausal women
           not using adjuvant AI therapy.

        -  To determine if adjuvant AI therapy use is associated with greater alveolar bone loss or
           increased levels of bone turnover biomarkers in postmenopausal women with cancer
           undergoing adjuvant AI therapy compared to postmenopausal women not receiving AI
           therapy.

        -  To determine the oral health-related quality of life among postmenopausal women with
           early stage breast cancer who are receiving adjuvant AI therapy.
time perspective: Cross-Sectional
measure: Periodontal diseases
time frame: At the time of study visit
measure: Alveolar bone loss using salivary and serum-derived bone markers.
time frame: At the time of study visit
measure: Oral Health Related Quality of Life (OHRQoL) assessed via questionnaire
time frame: At the time of study visit
arm group label: Aromatase Inhibitor
description: Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara
arm group label: No Treatment
description: Healthy volunteer postmenopausal women not taking Aromatase Inhibitors
Each patient will have 5ml of blood collected at the visit. Saliva, and urine will also be
      collected at the study visit.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: L. Susan Taichman, RDH MPH PhD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Linda Susan Taichman
investigator title: Principal Investigator
mesh term: Periodontal Diseases