<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/NCT01663246</url>
  </required_header>
  <id_info>
    <org_study_id>2005.097</org_study_id>
    <secondary_id>HUM00000970</secondary_id>
    <nct_id>NCT01663246</nct_id>
  </id_info>
  <brief_title>Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer</brief_title>
  <official_title>Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are conducting research about oral health and saliva to find out more about&#xD;
      the impact of radiation therapy on the oral health of patients.&#xD;
&#xD;
      In order to better understand the role of saliva in maintaining oral health in these&#xD;
      patients, the investigators will be collecting, storing, and analyzing the quality of saliva,&#xD;
      including the protein content, collected from patients following radiation therapy as well as&#xD;
      saliva collected from normal healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Radiation-induced xerostomia is the most common long term complication of head and neck&#xD;
      radiation, is usually permanent and is the most frequent reason for reduced quality of life&#xD;
      in these patients. The loss of antimicrobial, buffering, cleansing and remineralizing effects&#xD;
      of saliva markedly increases the risk for dental caries. Extractions of diseased teeth&#xD;
      located in irradiated bone and dental infection involving the bone can trigger&#xD;
      osteoradionecrosis (ORN), another serious complication of high dose radiation of the jaws.&#xD;
      Therefore, current dental treatment guidelines recommend the extraction of diseased teeth and&#xD;
      any teeth that might require extraction in the future, before radiation therapy. (NCI, 1990;&#xD;
      Rankin et al, 2003; NIDCR, 2005) As a result, patients with head and neck cancer often have&#xD;
      many or all teeth extracted, especially those patients who are judged unlikely to comply with&#xD;
      lifelong, daily topical fluoride, oral hygiene practices and frequent professional dental&#xD;
      care. (Bruins et al, 1999)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2006</start_date>
  <completion_date type="Actual">December 2008</completion_date>
  <primary_completion_date type="Actual">October 2007</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>prevalence of dental caries in patients after PS-IMRT</measure>
    <time_frame>24 Months</time_frame>
    <description>Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products</description>
  </primary_outcome>
  <primary_outcome>
    <measure>prevalence of tooth loss in patients after PS-IMRT</measure>
    <time_frame>24 months</time_frame>
    <description>Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prevalence of periodontal disease after PS-IMRT</measure>
    <time_frame>24 Months</time_frame>
    <description>number of caries in individual subjects will depend on number of teeth and/or surfaces at risk, we will need to report &quot;prevalence&quot; after adjusting for the total surfaces at risk for each patient. In addition, because data in the cross-sectional cohort will be obtained from patients at different follow-up times since RT, the relationship between prevalence and time since RT will need to be explored to take into account the time effect.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Healthy Adults</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy adults over the age of 18, with no history of surgery to the salivary glands, or cancer therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiation for Head and Neck Cancer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>History of radiation therapy for head and neck cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Saliva Sample</intervention_name>
    <description>Small plastic cups will be placed on the inside of subject cheeks, and held in place with gentle suction. These cups are attached to tubes which will allow the collection of saliva into a test tube. Saliva will also be collected from the glands underneath the tongue using a small gentle suction device, similar to the one used by a dentist. Saliva production will be stimulated by dabbing a mild citric acid solution that tastes like lemon onto the tongue using a Q-Tip. After this test, subjects will also be asked to chew wax to simulate saliva, and the saliva that accumulates in their mouth will be collected by spitting into a test tube.</description>
    <arm_group_label>Healthy Adults</arm_group_label>
    <arm_group_label>Radiation for Head and Neck Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All subjects who have been enrolled in a parotid-sparing IMRT protocol for head and&#xD;
             neck cancer at University of Michigan.&#xD;
&#xD;
          -  At least 6 months has elapsed since the completion of RT, at the time of assessment&#xD;
             for this study.&#xD;
&#xD;
          -  All subjects must sign a University of Michigan Health System- IRB approved informed&#xD;
             consent.&#xD;
&#xD;
          -  Documented Karnofsky performance status &gt; 60&#xD;
&#xD;
          -  These subjects will all have American Joint Committee on Cancer (AJCC) Stage III or&#xD;
             Stage IV disease. (Green et al, 2001) (Appendix 2); non-metastatic, curable disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of surgical removal of major salivary gland(s).&#xD;
&#xD;
          -  Patients edentulous prior to radiation therapy.&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Patients residing in prison.&#xD;
&#xD;
          -  Age&lt; 18 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Avraham Eisbruch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Rogel Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan Rogel Cancer Center</investigator_affiliation>
    <investigator_full_name>Avraham Eisbruch</investigator_full_name>
    <investigator_title>Newman Family Professor of Radiation Oncology and Professor of Radiation</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</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/NCT01663246
org study id: 2005.097
secondary id: HUM00000970
nct id: NCT01663246
lead sponsor: 
has dmc: Yes
The investigators are conducting research about oral health and saliva to find out more about
      the impact of radiation therapy on the oral health of patients.

      In order to better understand the role of saliva in maintaining oral health in these
      patients, the investigators will be collecting, storing, and analyzing the quality of saliva,
      including the protein content, collected from patients following radiation therapy as well as
      saliva collected from normal healthy adults.
Radiation-induced xerostomia is the most common long term complication of head and neck
      radiation, is usually permanent and is the most frequent reason for reduced quality of life
      in these patients. The loss of antimicrobial, buffering, cleansing and remineralizing effects
      of saliva markedly increases the risk for dental caries. Extractions of diseased teeth
      located in irradiated bone and dental infection involving the bone can trigger
      osteoradionecrosis (ORN), another serious complication of high dose radiation of the jaws.
      Therefore, current dental treatment guidelines recommend the extraction of diseased teeth and
      any teeth that might require extraction in the future, before radiation therapy. (NCI, 1990;
      Rankin et al, 2003; NIDCR, 2005) As a result, patients with head and neck cancer often have
      many or all teeth extracted, especially those patients who are judged unlikely to comply with
      lifelong, daily topical fluoride, oral hygiene practices and frequent professional dental
      care. (Bruins et al, 1999)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: prevalence of dental caries in patients after PS-IMRT
time frame: 24 Months
description: Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products
measure: prevalence of tooth loss in patients after PS-IMRT
time frame: 24 months
description: Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products
measure: prevalence of periodontal disease after PS-IMRT
time frame: 24 Months
description: number of caries in individual subjects will depend on number of teeth and/or surfaces at risk, we will need to report "prevalence" after adjusting for the total surfaces at risk for each patient. In addition, because data in the cross-sectional cohort will be obtained from patients at different follow-up times since RT, the relationship between prevalence and time since RT will need to be explored to take into account the time effect.
arm group label: Healthy Adults
arm group type: Active Comparator
description: Healthy adults over the age of 18, with no history of surgery to the salivary glands, or cancer therapy.
arm group label: Radiation for Head and Neck Cancer
arm group type: Active Comparator
description: History of radiation therapy for head and neck cancer.
intervention type: Procedure
intervention name: Saliva Sample
description: Small plastic cups will be placed on the inside of subject cheeks, and held in place with gentle suction. These cups are attached to tubes which will allow the collection of saliva into a test tube. Saliva will also be collected from the glands underneath the tongue using a small gentle suction device, similar to the one used by a dentist. Saliva production will be stimulated by dabbing a mild citric acid solution that tastes like lemon onto the tongue using a Q-Tip. After this test, subjects will also be asked to chew wax to simulate saliva, and the saliva that accumulates in their mouth will be collected by spitting into a test tube.
arm group label: Healthy Adults
arm group label: Radiation for Head and Neck Cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Avraham Eisbruch, MD
role: Principal Investigator
affiliation: University of Michigan Rogel Cancer Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan Rogel Cancer Center
investigator full name: Avraham Eisbruch
investigator title: Newman Family Professor of Radiation Oncology and Professor of Radiation
mesh term: Head and Neck Neoplasms