<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/NCT03822572</url>
  </required_header>
  <id_info>
    <org_study_id>ABCSG C08</org_study_id>
    <nct_id>NCT03822572</nct_id>
  </id_info>
  <brief_title>ABCSG C08-Exercise II: Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer</brief_title>
  <acronym>ABCSG C08</acronym>
  <official_title>ABCSG C08 - Exercise II: Randomized Trial of Endurance Exercise Following Adjuvant Chemotherapy for Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Austrian Breast &amp; Colorectal Cancer Study Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oberösterreichische Krebshilfe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Austrian Breast &amp; Colorectal Cancer Study Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ABCSG C08 is a randomized, two-arm, multicenter trial to investigate the efficacy of&#xD;
      endurance exercise following adjuvant chemotherapy in patients with colorectal cancer.&#xD;
&#xD;
      Indication: Locally advanced colorectal cancer after adjuvant chemotherapy. Evidence&#xD;
      supporting the beneficial effects of exercise programs during chemotherapy are available, the&#xD;
      results across studies are not entirely consistent. Additional studies are needed to&#xD;
      determine the optimal content, intensity, and form of training programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer is the second leading cause of cancer mortality in Western countries after&#xD;
      breast cancer among women and lung cancer among men. About 5.000 new cases are diagnosed each&#xD;
      year in Austria. This represents an annual incidence of 50-60 per 100.000 inhabitants. In&#xD;
      patients with colorectal cancer stage III and in certain situations even in stage II adjuvant&#xD;
      chemotherapy is indicated after R0 resection. Despite recent advances in adjuvant&#xD;
      chemotherapy 20-30% of these patients still relapse. About 80% of recurrences occur in the&#xD;
      first three years.&#xD;
&#xD;
      There is consistent evidence from several observational epidemiologic studies that physical&#xD;
      activity reduces the risk of developing colon cancer. In recent years several observational&#xD;
      studies even showed a reduction in relapse rate, colon cancer-specific mortality and overall&#xD;
      mortality by physical activity in patients with colon and breast cancer. Colon cancer&#xD;
      survivors who engaged in higher levels of physical activity experienced a 50-60% improvement&#xD;
      in long-term outcomes compared to inactive patients. Different mechanisms for the protective&#xD;
      effect of physical activity on colon cancer have been proposed and it is believed that the&#xD;
      same mechanisms of physical activity are also involved in the improvement of disease outcomes&#xD;
      in gastrointestinal cancer survivors. Physical activity leads to decrease of inflammation,&#xD;
      decreased levels of insulin-like growth factor (IGF) and insulin, reduced transit time&#xD;
      through the gut and increased levels of vitamin D. Factors, that are associated with a&#xD;
      reduced risk of colon polyps, colon cancer and colon cancer mortality.&#xD;
&#xD;
      A review on the impact of various exercise programs on fatigue, found good evidence that&#xD;
      exercise not only decreased levels of fatigue, but also increased quality of life, mood and&#xD;
      functioning.&#xD;
&#xD;
      While there is evidence supporting the beneficial effects of exercise programs during&#xD;
      chemotherapy, the results across studies are not entirely consistent. Additional studies are&#xD;
      needed to determine the optimal content, intensity, and form of training programs.&#xD;
&#xD;
      Recently ABCSG has investigated the feasibility of endurance exercise after adjuvant&#xD;
      chemotherapy in patients with locally advanced colorectal cancer in the investigator's study&#xD;
      group (ABCSG C07 Exercise - pilot study). Results concerning compliance of patients have been&#xD;
      considered for sample size estimations and study planning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Endpoint - disease free survival (DFS)</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>DFS is defined as the time from randomization to locoregional or metastatic recurrence or the appearance of secondary cancer or death, whichever occurs first. Recurrence may be either histologically proven or evidenced by imaging via MRI or CT. Isolated CEA evaluation will not be sufficient to determine a relapse.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint I - relapse free survival (RFS)</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>RFS is defined as the time from randomization to locoregional or metastatic recurrence of colorectal cancer or death, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint II - overall survival (OS)</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>OS is defined as time from randomization to death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Endpoint I - physical activity measured by MET-hours</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of physical activities measured by MET-hours in the domains &quot;work&quot;, &quot;leisure time &quot;, &quot;sedentary behavior&quot; and &quot;transporation&quot; by Global Physical Activity Questionnaire (GPAQ) within each study arm and compared between study arms at baseline, at 3, at 6, at 12, at 24 and at 36 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Endpoint II - endurance exercise measured by MET-hours</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of endurance exercise measured by MET-hours by pulse-control in arm A at 3, at 6 and at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Endpoint III - performance enhancement measured by MET-hours by ergometry</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of performance enhancement measured by MET-hours by ergometry within each study arm (arm A at baseline, at 3, at 6 and at 12 months; arm B at baseline and at 12 months) and compared between study arms at baseline and at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Endpoint IV - physical activity measures</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Correlation of MET-hours in the domains &quot;work&quot;, &quot;leisure time &quot;, &quot;sedentary behavior&quot; and &quot;transporation&quot; by Global Physical Activity Questionnaire (GPAQ) and results of endurance exercise as well as performance enhancement by ergometry (both measured by MET-hours) with DFS, RFS and OS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome Endpoint I - fatigue</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of fatigue as measured by EORTC - QLQ FATIGUE CAT Theta scores compared between study arms. Score has no fixed upper and lower limit and a high score represents a high level of fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome Endpoint II - emotional functioning score</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of the emotional functioning score (based in the functional scale EF) as measured by EORTC QLQ-C30 emotional functioning (based on items) compared between study arms, where a high score for a functional scale represents a high/healthy level of functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome Endpoint III - physical functioning score</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of the standardized physical functioning score (based on the revised functional scale PF2) as measured by EORTC QLQ-C30 physical functioning compared between study arms, where a high score for a functional scale represents a high/healthy level of functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome Endpoint IV - global quality of life (QoL) score</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of the standardized global health status/QoL score (based on the revised global health status/QoL QL2) as measured by EORTC QLQ-C30 summary score compared between study arms, where a high score for the global health status/QoL represents a high QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome Endpoint V - patient reported outcomes (fatigue, emotional functioning, physical functioning, global quality of life)</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Correlation of all patient reported outcomes explained above (fatigue, emotional functioning, physical functioning, global quality of life) with MET-hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition Endpoint I - body mass index (BMI)</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of the influence of BMI on DFS, RFS and OS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition Endpoint II - body fat</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of the influence of body fat on DFS, RFS and OS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition Endpoint III - waist circumference</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of the influence of waist circumference on DFS, RFS and OS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Endpoint - cardiovascular complications</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of the incidence of cardiovascular complications (myocardial infarction, stroke, newly diagnosed diabetes mellitus, newly diagnosed hypertension)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Endpoint I - serious adverse events (SAEs)</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of the incidence of physical activity related SAEs and physical activity related deaths in both arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Endpoint II - time to SAEs</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Evaluation of time from study start to physical activity related SAEs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory Endpoint - molecular and biochemical markers (will be defined during the course of the study)</measure>
    <time_frame>8 years (after Last Patient Out (LPO))</time_frame>
    <description>Correlation of molecular and biochemical markers with DFS, RFS, OS and with physical activity. The analysis of molecular markers will depend on the markers which will be defined during the course of the study in addition to Insulin &amp; ILGF.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">788</enrollment>
  <condition>Colorectal Carcinoma</condition>
  <arm_group>
    <arm_group_label>A - endurance exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients receive a pulse-controlled endurance exercise program based on the study results by O'Donovan. The individual pulse-controlled endurance exercise should be performed 3 times a week. On the basis of age, weight, sex and body fat the normal weight will be calculated. The kilocalories (kcal), which correspond to the metabolic equivalent task (MET) hour per week, will be calculated after age and gender adjustment of the normal weight. The endurance exercise will be increased gradually until reaching 18 MET-hours/wk during the year of endurance exercise. Patients in arm A can perform different types of endurance exercise (bicycling, cross walking, jogging, walking, nordic walking, cross country skiing)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - control arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in this arm should maintain their habitual physical activity pattern as before the diagnoses of colorectal cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>endurance exercise</intervention_name>
    <description>defined exercise program</description>
    <arm_group_label>A - endurance exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control</intervention_name>
    <description>habitual physical activity before the diagnosis</description>
    <arm_group_label>B - control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  completely resected, histologically confirmed adenocarcinoma of the colon or rectum&#xD;
&#xD;
          -  patients, who have completed adjuvant chemotherapy 4-16 weeks prior to randomization&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  adequate hematologic functions &lt;=28d prior to randomization&#xD;
&#xD;
          -  able to perform endurance exercise according to protocol&#xD;
&#xD;
          -  ability to perform ergometry in order to assess physical capability at the discretion&#xD;
             of the investigator&#xD;
&#xD;
          -  signed informed consent prior to randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  significant comorbid conditions precluding participation in a physical activity&#xD;
             program (investigators decision)&#xD;
&#xD;
          -  disabled patients unable to participate in the physical activity program&#xD;
&#xD;
          -  Regular (3-times a week) vigorous physical activity of &gt;150 minutes (type of physical&#xD;
             activity: bicycling, cross walking (cross trainer), jogging, walking at a brisk pace,&#xD;
             nordic walking, cross country skiing) within the last year before diagnosis of&#xD;
             colorectal cancer&#xD;
&#xD;
          -  patients unwilling to complete endurance exercise or complete all questionnaires&#xD;
             related to the study&#xD;
&#xD;
          -  past or current history of other malignant neoplasms other than colorectal cancer in&#xD;
             the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of&#xD;
             the cervix&#xD;
&#xD;
          -  clinically significant cardiovascular disease&#xD;
&#xD;
          -  left bundle branch block&#xD;
&#xD;
          -  current study with chemotherapy or radiation&#xD;
&#xD;
          -  current pregnancy or plans to become pregnant within the next 3 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josef Thaler, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Austrian Breast &amp; Colorectal Cancer Study Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martina Putz, PhD</last_name>
    <phone>+43 1 4089230</phone>
    <email>martina.putz@abcsg.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aleksandra Mystek, BBSc</last_name>
    <phone>+43 1 4089230</phone>
    <email>aleksandra.mystek@abcsg.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Med. Univ. Graz</name>
      <address>
        <city>Graz</city>
        <state>Styria</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Bauernhofer, MD</last_name>
    </contact>
    <investigator>
      <last_name>Thomas Bauernhofer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>BKH Kufstein</name>
      <address>
        <city>Kufstein</city>
        <state>Tyrol</state>
        <zip>6330</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>August Zabernigg, MD, Head</last_name>
    </contact>
    <investigator>
      <last_name>August Zabernigg, MD, Head</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>KH St. Josef Braunau</name>
      <address>
        <city>Braunau Am Inn</city>
        <state>Upper Austria</state>
        <zip>5280</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sigrid Kastl, MD, Head</last_name>
    </contact>
    <investigator>
      <last_name>Sigrid Kastl, MD, Head</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital BHS Linz, Coop. Study Group</name>
      <address>
        <city>Linz</city>
        <state>Upper Austria</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Petzer, MD, Head</last_name>
    </contact>
    <investigator>
      <last_name>Andreas Petzer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kepler Universitätsklinikum Linz</name>
      <address>
        <city>Linz</city>
        <state>Upper Austria</state>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gerhard Hochreiner, MD</last_name>
    </contact>
    <investigator>
      <last_name>Hochreiner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital BHS Ried</name>
      <address>
        <city>Ried</city>
        <state>Upper Austria</state>
        <zip>4910</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>State Hospital Steyr</name>
      <address>
        <city>Steyr</city>
        <state>Upper Austria</state>
        <zip>4400</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johannes Andel, MD, Head</last_name>
    </contact>
    <investigator>
      <last_name>Johannes Andel, MD, Head</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen</name>
      <address>
        <city>Wels</city>
        <state>Upper Austria</state>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josef Thaler, MD, Head</last_name>
    </contact>
    <investigator>
      <last_name>Josef Thaler, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>LKH Salzburg-PMU, UNiv. KLinik f. Innere Med III</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard Greil, MD, Head</last_name>
    </contact>
    <investigator>
      <last_name>Richard Greil, MD, Head</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endurance exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>currently sharing of IPDs (Individual Participant Data) is not planned in this trial</ipd_description>
  </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/NCT03822572
org study id: ABCSG C08
nct id: NCT03822572
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
ABCSG C08 is a randomized, two-arm, multicenter trial to investigate the efficacy of
      endurance exercise following adjuvant chemotherapy in patients with colorectal cancer.

      Indication: Locally advanced colorectal cancer after adjuvant chemotherapy. Evidence
      supporting the beneficial effects of exercise programs during chemotherapy are available, the
      results across studies are not entirely consistent. Additional studies are needed to
      determine the optimal content, intensity, and form of training programs.
Colorectal cancer is the second leading cause of cancer mortality in Western countries after
      breast cancer among women and lung cancer among men. About 5.000 new cases are diagnosed each
      year in Austria. This represents an annual incidence of 50-60 per 100.000 inhabitants. In
      patients with colorectal cancer stage III and in certain situations even in stage II adjuvant
      chemotherapy is indicated after R0 resection. Despite recent advances in adjuvant
      chemotherapy 20-30% of these patients still relapse. About 80% of recurrences occur in the
      first three years.

      There is consistent evidence from several observational epidemiologic studies that physical
      activity reduces the risk of developing colon cancer. In recent years several observational
      studies even showed a reduction in relapse rate, colon cancer-specific mortality and overall
      mortality by physical activity in patients with colon and breast cancer. Colon cancer
      survivors who engaged in higher levels of physical activity experienced a 50-60% improvement
      in long-term outcomes compared to inactive patients. Different mechanisms for the protective
      effect of physical activity on colon cancer have been proposed and it is believed that the
      same mechanisms of physical activity are also involved in the improvement of disease outcomes
      in gastrointestinal cancer survivors. Physical activity leads to decrease of inflammation,
      decreased levels of insulin-like growth factor (IGF) and insulin, reduced transit time
      through the gut and increased levels of vitamin D. Factors, that are associated with a
      reduced risk of colon polyps, colon cancer and colon cancer mortality.

      A review on the impact of various exercise programs on fatigue, found good evidence that
      exercise not only decreased levels of fatigue, but also increased quality of life, mood and
      functioning.

      While there is evidence supporting the beneficial effects of exercise programs during
      chemotherapy, the results across studies are not entirely consistent. Additional studies are
      needed to determine the optimal content, intensity, and form of training programs.

      Recently ABCSG has investigated the feasibility of endurance exercise after adjuvant
      chemotherapy in patients with locally advanced colorectal cancer in the investigator's study
      group (ABCSG C07 Exercise - pilot study). Results concerning compliance of patients have been
      considered for sample size estimations and study planning.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Primary Endpoint - disease free survival (DFS)
time frame: 8 years (after Last Patient Out (LPO))
description: DFS is defined as the time from randomization to locoregional or metastatic recurrence or the appearance of secondary cancer or death, whichever occurs first. Recurrence may be either histologically proven or evidenced by imaging via MRI or CT. Isolated CEA evaluation will not be sufficient to determine a relapse.
measure: Secondary Efficacy Endpoint I - relapse free survival (RFS)
time frame: 8 years (after Last Patient Out (LPO))
description: RFS is defined as the time from randomization to locoregional or metastatic recurrence of colorectal cancer or death, whichever occurs first
measure: Secondary Efficacy Endpoint II - overall survival (OS)
time frame: 8 years (after Last Patient Out (LPO))
description: OS is defined as time from randomization to death from any cause
measure: Physical Activity Endpoint I - physical activity measured by MET-hours
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of physical activities measured by MET-hours in the domains "work", "leisure time ", "sedentary behavior" and "transporation" by Global Physical Activity Questionnaire (GPAQ) within each study arm and compared between study arms at baseline, at 3, at 6, at 12, at 24 and at 36 months
measure: Physical Activity Endpoint II - endurance exercise measured by MET-hours
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of endurance exercise measured by MET-hours by pulse-control in arm A at 3, at 6 and at 12 months
measure: Physical Activity Endpoint III - performance enhancement measured by MET-hours by ergometry
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of performance enhancement measured by MET-hours by ergometry within each study arm (arm A at baseline, at 3, at 6 and at 12 months; arm B at baseline and at 12 months) and compared between study arms at baseline and at 12 months
measure: Physical Activity Endpoint IV - physical activity measures
time frame: 8 years (after Last Patient Out (LPO))
description: Correlation of MET-hours in the domains "work", "leisure time ", "sedentary behavior" and "transporation" by Global Physical Activity Questionnaire (GPAQ) and results of endurance exercise as well as performance enhancement by ergometry (both measured by MET-hours) with DFS, RFS and OS
measure: Patient Reported Outcome Endpoint I - fatigue
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of fatigue as measured by EORTC - QLQ FATIGUE CAT Theta scores compared between study arms. Score has no fixed upper and lower limit and a high score represents a high level of fatigue.
measure: Patient Reported Outcome Endpoint II - emotional functioning score
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of the emotional functioning score (based in the functional scale EF) as measured by EORTC QLQ-C30 emotional functioning (based on items) compared between study arms, where a high score for a functional scale represents a high/healthy level of functioning.
measure: Patient Reported Outcome Endpoint III - physical functioning score
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of the standardized physical functioning score (based on the revised functional scale PF2) as measured by EORTC QLQ-C30 physical functioning compared between study arms, where a high score for a functional scale represents a high/healthy level of functioning
measure: Patient Reported Outcome Endpoint IV - global quality of life (QoL) score
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of the standardized global health status/QoL score (based on the revised global health status/QoL QL2) as measured by EORTC QLQ-C30 summary score compared between study arms, where a high score for the global health status/QoL represents a high QoL.
measure: Patient Reported Outcome Endpoint V - patient reported outcomes (fatigue, emotional functioning, physical functioning, global quality of life)
time frame: 8 years (after Last Patient Out (LPO))
description: Correlation of all patient reported outcomes explained above (fatigue, emotional functioning, physical functioning, global quality of life) with MET-hours
measure: Body Composition Endpoint I - body mass index (BMI)
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of the influence of BMI on DFS, RFS and OS
measure: Body Composition Endpoint II - body fat
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of the influence of body fat on DFS, RFS and OS
measure: Body Composition Endpoint III - waist circumference
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of the influence of waist circumference on DFS, RFS and OS
measure: Cardiovascular Endpoint - cardiovascular complications
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of the incidence of cardiovascular complications (myocardial infarction, stroke, newly diagnosed diabetes mellitus, newly diagnosed hypertension)
measure: Safety Endpoint I - serious adverse events (SAEs)
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of the incidence of physical activity related SAEs and physical activity related deaths in both arms
measure: Safety Endpoint II - time to SAEs
time frame: 8 years (after Last Patient Out (LPO))
description: Evaluation of time from study start to physical activity related SAEs
measure: Exploratory Endpoint - molecular and biochemical markers (will be defined during the course of the study)
time frame: 8 years (after Last Patient Out (LPO))
description: Correlation of molecular and biochemical markers with DFS, RFS, OS and with physical activity. The analysis of molecular markers will depend on the markers which will be defined during the course of the study in addition to Insulin & ILGF.
arm group label: A - endurance exercise
arm group type: Experimental
description: All patients receive a pulse-controlled endurance exercise program based on the study results by O'Donovan. The individual pulse-controlled endurance exercise should be performed 3 times a week. On the basis of age, weight, sex and body fat the normal weight will be calculated. The kilocalories (kcal), which correspond to the metabolic equivalent task (MET) hour per week, will be calculated after age and gender adjustment of the normal weight. The endurance exercise will be increased gradually until reaching 18 MET-hours/wk during the year of endurance exercise. Patients in arm A can perform different types of endurance exercise (bicycling, cross walking, jogging, walking, nordic walking, cross country skiing)
arm group label: B - control arm
arm group type: Other
description: Patients in this arm should maintain their habitual physical activity pattern as before the diagnoses of colorectal cancer.
intervention type: Other
intervention name: endurance exercise
description: defined exercise program
arm group label: A - endurance exercise
intervention type: Other
intervention name: control
description: habitual physical activity before the diagnosis
arm group label: B - control arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Josef Thaler, MD
role: Study Chair
affiliation: Austrian Breast & Colorectal Cancer Study Group
last name: Martina Putz, PhD
phone: +43 1 4089230
email: martina.putz@abcsg.at
last name: Aleksandra Mystek, BBSc
phone: +43 1 4089230
email: aleksandra.mystek@abcsg.at
facility: 
status: Recruiting
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status: Withdrawn
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country: Austria
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No
ipd description: currently sharing of IPDs (Individual Participant Data) is not planned in this trial