<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/NCT02251730</url>
  </required_header>
  <id_info>
    <org_study_id>201406075RINC</org_study_id>
    <nct_id>NCT02251730</nct_id>
  </id_info>
  <brief_title>Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy</brief_title>
  <official_title>A Feasibility and Efficacy Study of Smoking Cessation Program in Head and Neck Cancer Patients Receiving Curative Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To propose a feasibility study of introducing a smoking cessation program in head and neck&#xD;
      cancer patients with planned radiotherapy. The study will feature the feasibility, safety,&#xD;
      and efficacy of a prospective smoking cessation program during head and neck irradiation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking during radiotherapy in head and neck cancers yields not only more radiotherapy acute&#xD;
      and late complications but also poor clinical tumor response, poor local control, and poor&#xD;
      overall survival. However, smoking cessation has not been included into the standard&#xD;
      intervention in treating head and neck cancer patients in Taiwan. We propose a prospective&#xD;
      study of introducing a smoking cessation program in head and neck cancer patients receiving&#xD;
      radiotherapy. The study will feature the feasibility, safety, and efficacy of a prospective&#xD;
      smoking cessation program during head and neck irradiation. The primary outcome is to test&#xD;
      the feasibility of the smoking cessation intervention, and the secondary outcome is to test&#xD;
      the efficacy of the intervention during radiotherapy on acute and late RT toxicities, tumor&#xD;
      response, patterns of relapse, and overall survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 2</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>Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less.</measure>
    <time_frame>10 weeks</time_frame>
    <description>The primary outcome was to test the feasibility of introducing a smoking cessation program in head and neck cancer patients undergoing radiotherapy. Smoking cessation status will be formally assessed by patient report and by carbon monoxide (CO) breath test. The status of tobacco abstinence will be confirmed by carbon monoxide breath test concentrations of 3 ppm or less.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>≥ Grade 3 acute and late adverse event</measure>
    <time_frame>2 years</time_frame>
    <description>The secondary outcomes were to test the efficacy of smoking cessation during radiotherapy on acute and late radiation therapy toxicities, tumor response, patterns of relapse, and overall survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One- and two-year local-regional control rates</measure>
    <time_frame>2 years</time_frame>
    <description>All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One- and two-year distant metastases-free survival rates</measure>
    <time_frame>2 years</time_frame>
    <description>All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One- and two-year progression-free survival rates</measure>
    <time_frame>2 years</time_frame>
    <description>All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>Refer for smoking cessation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Refer for smoking cessation</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking cessation</intervention_name>
    <description>Refer for smoking cessation</description>
    <arm_group_label>Refer for smoking cessation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 70 years&#xD;
&#xD;
          -  Head and Neck Malignancy Stage I-IVB without distant metastasis&#xD;
&#xD;
          -  Receiving five weeks or more of external beam radiotherapy&#xD;
&#xD;
          -  Report smoking one or more cigarettes in the past 30 days or self-identify as a smoker&#xD;
&#xD;
          -  KPS 70-100&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic&#xD;
             disorders, as assessed by the study-site physician&#xD;
&#xD;
          -  A current diagnosis of major depressive episode or a history of psychosis, bipolar&#xD;
             disorder, or seizure disorder&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jenny Ling-Yu Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>May 11, 2016</last_update_submitted>
  <last_update_submitted_qc>May 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>radiation therapy,Smoking pattern,head and neck cancer</keyword>
  <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/NCT02251730
org study id: 201406075RINC
nct id: NCT02251730
lead sponsor: 
has dmc: No
To propose a feasibility study of introducing a smoking cessation program in head and neck
      cancer patients with planned radiotherapy. The study will feature the feasibility, safety,
      and efficacy of a prospective smoking cessation program during head and neck irradiation.
Smoking during radiotherapy in head and neck cancers yields not only more radiotherapy acute
      and late complications but also poor clinical tumor response, poor local control, and poor
      overall survival. However, smoking cessation has not been included into the standard
      intervention in treating head and neck cancer patients in Taiwan. We propose a prospective
      study of introducing a smoking cessation program in head and neck cancer patients receiving
      radiotherapy. The study will feature the feasibility, safety, and efficacy of a prospective
      smoking cessation program during head and neck irradiation. The primary outcome is to test
      the feasibility of the smoking cessation intervention, and the secondary outcome is to test
      the efficacy of the intervention during radiotherapy on acute and late RT toxicities, tumor
      response, patterns of relapse, and overall survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less.
time frame: 10 weeks
description: The primary outcome was to test the feasibility of introducing a smoking cessation program in head and neck cancer patients undergoing radiotherapy. Smoking cessation status will be formally assessed by patient report and by carbon monoxide (CO) breath test. The status of tobacco abstinence will be confirmed by carbon monoxide breath test concentrations of 3 ppm or less.
measure: ≥ Grade 3 acute and late adverse event
time frame: 2 years
description: The secondary outcomes were to test the efficacy of smoking cessation during radiotherapy on acute and late radiation therapy toxicities, tumor response, patterns of relapse, and overall survival.
measure: One- and two-year local-regional control rates
time frame: 2 years
description: All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group.
measure: One- and two-year distant metastases-free survival rates
time frame: 2 years
description: All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group.
measure: One- and two-year progression-free survival rates
time frame: 2 years
description: All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group.
arm group label: Refer for smoking cessation
arm group type: Experimental
description: Refer for smoking cessation
intervention type: Behavioral
intervention name: Smoking cessation
description: Refer for smoking cessation
arm group label: Refer for smoking cessation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jenny Ling-Yu Chen
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms