<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/NCT01700283</url>
  </required_header>
  <id_info>
    <org_study_id>201208026RIC</org_study_id>
    <nct_id>NCT01700283</nct_id>
  </id_info>
  <brief_title>Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.</brief_title>
  <official_title>Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of this four-year study are to&#xD;
&#xD;
        1. Explore exercise behavior, exercise barriers, and identify the significant factors for&#xD;
           exercise behavior in colorectal cancer survivors.&#xD;
&#xD;
        2. Explore the relationships among fatigue, muscle strength, and metabolomics and further&#xD;
           examine the possible biomarkers from muscle strength and metabolomics for fatigue.&#xD;
&#xD;
        3. Develop a clinical guidelines of home-based fatigue management and exercise program and&#xD;
           test its effect on decreasing fatigue for patients with colorectal cancer after surgery&#xD;
           in Taiwan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors</measure>
    <time_frame>four-year study</time_frame>
    <description>Develope the clinical exercise education program guideline for patients with early stage colorectal cancer survivor.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">306</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>exercise education and walking program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>maintain their daily activity</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>exercise education and walking program</intervention_name>
    <description>12-week moderate intensity walking program</description>
    <arm_group_label>exercise education and walking program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Colorectal cancer survivors completed treatment at least 3 months in clinics.&#xD;
&#xD;
          -  Aged above 20.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  KPS &lt; 60&#xD;
&#xD;
          -  Stage 4&#xD;
&#xD;
          -  Bone meta&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiow-Ching Shun, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shiow-Ching Shun, PHD</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>88439</phone_ext>
    <email>scshun@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shiow-Ching Shun, PHD</last_name>
      <phone>886-2-2312-3456</phone>
      <phone_ext>88439</phone_ext>
      <email>scshun@ntu.edu.tw</email>
    </contact>
    <investigator>
      <last_name>Shiow-Ching Shun, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Cancer、Fatigue、Muscle strength、Metabolomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Fatigue</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/NCT01700283
org study id: 201208026RIC
nct id: NCT01700283
lead sponsor: 
collaborator: 
has dmc: Yes
The aims of this four-year study are to

        1. Explore exercise behavior, exercise barriers, and identify the significant factors for
           exercise behavior in colorectal cancer survivors.

        2. Explore the relationships among fatigue, muscle strength, and metabolomics and further
           examine the possible biomarkers from muscle strength and metabolomics for fatigue.

        3. Develop a clinical guidelines of home-based fatigue management and exercise program and
           test its effect on decreasing fatigue for patients with colorectal cancer after surgery
           in Taiwan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors
time frame: four-year study
description: Develope the clinical exercise education program guideline for patients with early stage colorectal cancer survivor.
arm group label: exercise education and walking program
arm group type: Experimental
arm group label: maintain their daily activity
arm group type: No Intervention
intervention type: Behavioral
intervention name: exercise education and walking program
description: 12-week moderate intensity walking program
arm group label: exercise education and walking program
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Shiow-Ching Shun, PhD
role: Principal Investigator
affiliation: National Taiwan University
last name: Shiow-Ching Shun, PHD
phone: 886-2-23123456
phone ext: 88439
email: scshun@ntu.edu.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Fatigue