<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/NCT03291951</url>
  </required_header>
  <id_info>
    <org_study_id>CN-17-2877</org_study_id>
    <nct_id>NCT03291951</nct_id>
  </id_info>
  <brief_title>FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study</brief_title>
  <acronym>FORCE</acronym>
  <official_title>FOcus on Reducing Dose-limiting Toxicities in Colon Cancer With Resistance Exercise Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>Yes</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>
      FORCE is a randomized home-based resistance training/strength training (RT) intervention&#xD;
      study for Stage II and III colon cancer patients undergoing chemotherapy.&#xD;
&#xD;
      Participants will be 180 newly diagnosed Stage II and III colon cancer patients from Kaiser&#xD;
      Permanente of Northern California (KPNC), the Penn State Cancer Institute (PSCI), and the&#xD;
      Dana Farber Cancer Institute (DFCI). The intervention will begin within the first weeks of&#xD;
      adjuvant chemotherapy and continue exercise through the completion of post-operative&#xD;
      chemotherapy. Specifically, the investigators will examine between group differences for RT&#xD;
      versus waitlist control for chemotherapy outcomes including dose delays, dose reductions,&#xD;
      early stoppage and Grade 3 and 4 toxicities. The investigators will also study changes in&#xD;
      muscle mass (MM) and changes in specific inflammatory markers (e.g. CRP, IL-6 and TNF-RII) as&#xD;
      potential markers of change in response to RT. To determine effects of change of MM on&#xD;
      chemotherapy-specific drug clearance, the investigators will examine the impact body&#xD;
      composition changes on the pharmacokinetics (PK) of 5-FU and oxaliplatin, two of the most&#xD;
      commonly used drugs for colon cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2018</start_date>
  <completion_date type="Actual">March 21, 2022</completion_date>
  <primary_completion_date type="Actual">March 21, 2022</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>
    <intervention_model_description>This randomized controlled trial of resistance training intervention in colon cancer patients receiving chemotherapy consists of two arms: an in-person and telephone-based intervention to promote home-based resistance training, and a wait-list, control group.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative dose intensity (RDI)</measure>
    <time_frame>3-6 months</time_frame>
    <description>Chemotherapy completion rates will be assessed as relative dose intensity for each agent and then average relative dose intensity (ARDI), which considers all chemotherapy agents in a regimen. We will examine differences in RDI for each chemotherapy agent and the ARDI across all agents between the RT group and the UC group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of moderate and severe chemotherapy-associated toxicities</measure>
    <time_frame>3-6 months</time_frame>
    <description>Moderate and severe chemotherapy-associated toxicities will be assessed via a NCI PRO-CTCAE questionnaire, which is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Resistance Training</condition>
  <condition>Colon Cancer</condition>
  <condition>Chemotherapy Effect</condition>
  <arm_group>
    <arm_group_label>Resistance training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the resistance training (RT) group will receive an in-person and telephone-based intervention to promote home-based resistance training. The exercise intervention will begin by the 3rd adjuvant chemotherapy visit and continue exercise through the completion of post-operative chemotherapy. Participants will work with an exercise professional with expertise working with oncology patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the usual care (U) group will be instructed to refer to their physician regarding what forms of exercise are safe for them, given their medical history. The U group will be told to continue whatever exercise program they have been undertaking up to enrolling in the study, but not to increase exercise or begin weight-lifting over the period of study participation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance training</intervention_name>
    <description>The intervention goal is for study participants to exercise with progressively higher weights for resistance training to achieve a 1-kg increase in lean body mass by the end of the intervention. During an in-person visit on the same day as a chemotherapy infusion session, exercise professionals will teach participants a series of exercises to be completed at home twice weekly throughout the intervention. Participants will also receive protein powder, which they will be instructed to consume with meals twice a day. During subsequent infusion sessions, the exercise professional will meet in-person with participants to evaluate their ability to increase weights, and adjust exercises appropriately. In between visits, the exercise professional will check-in with participants by phone.</description>
    <arm_group_label>Resistance training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women ≥18 years&#xD;
&#xD;
          -  Newly diagnosed with histologically confirmed stage II-Ill colon cancer&#xD;
&#xD;
          -  Completed curative-intent surgical resection&#xD;
&#xD;
          -  Currently prescribed one of the following adjuvant chemotherapy regimens: (IV&#xD;
             5-fluorouracil [5-FU] / leucovorin [LV], capecitabine, FOLFOX [5-FU, LV, oxaliplatin],&#xD;
             CAPOX [capecitabine and oxaliplatin]&#xD;
&#xD;
          -  Patients must have started chemotherapy or plan to start with receipt of the first&#xD;
             exercise visit by 3rd infusion visit. Patients enrolled at the Dana-Farber Cancer&#xD;
             Institute and who are receiving FOLFOX chemotherapy are eligible to enroll in the&#xD;
             pharmacokinetics sub-study.&#xD;
&#xD;
          -  No planned major surgery anticipated in the intervention period&#xD;
&#xD;
          -  Sufficient time to heal from any major surgery to start of intervention, including&#xD;
             colostomy reversal (port-a-cath removal excluded)&#xD;
&#xD;
          -  Approval by either oncologist or surgeon to participate in trial&#xD;
&#xD;
          -  Readiness as determined by the Physical Activity Readiness Questionnaire&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
             in English&#xD;
&#xD;
          -  Willingness to be randomized&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent actively treated other cancer (except non-melanoma skin cancer, in situ&#xD;
             cervical cancer or localized prostate cancer treated with surveillance only)&#xD;
&#xD;
          -  Patients with untreated hypertension (&gt;180 mm Hg systolic or &gt;100 mm Hg diastolic)&#xD;
             appearing in the patient's medical record in the two weeks prior to screening&#xD;
&#xD;
          -  Presence of metastatic disease&#xD;
&#xD;
          -  Current strength training &gt;2x week for the past 3 or more months&#xD;
&#xD;
          -  Patients enrolled in other clinical trials of weight loss, physical activity or&#xD;
             dietary interventions are ineligible.&#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>Bette J Caan, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kathryn H Schmitz, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Meyerhardt, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente Division of Research</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Cancer Institute</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 11, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03291951/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 9, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03291951/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03291951/ICF_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03291951
org study id: CN-17-2877
nct id: NCT03291951
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
FORCE is a randomized home-based resistance training/strength training (RT) intervention
      study for Stage II and III colon cancer patients undergoing chemotherapy.

      Participants will be 180 newly diagnosed Stage II and III colon cancer patients from Kaiser
      Permanente of Northern California (KPNC), the Penn State Cancer Institute (PSCI), and the
      Dana Farber Cancer Institute (DFCI). The intervention will begin within the first weeks of
      adjuvant chemotherapy and continue exercise through the completion of post-operative
      chemotherapy. Specifically, the investigators will examine between group differences for RT
      versus waitlist control for chemotherapy outcomes including dose delays, dose reductions,
      early stoppage and Grade 3 and 4 toxicities. The investigators will also study changes in
      muscle mass (MM) and changes in specific inflammatory markers (e.g. CRP, IL-6 and TNF-RII) as
      potential markers of change in response to RT. To determine effects of change of MM on
      chemotherapy-specific drug clearance, the investigators will examine the impact body
      composition changes on the pharmacokinetics (PK) of 5-FU and oxaliplatin, two of the most
      commonly used drugs for colon cancer.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This randomized controlled trial of resistance training intervention in colon cancer patients receiving chemotherapy consists of two arms: an in-person and telephone-based intervention to promote home-based resistance training, and a wait-list, control group.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Relative dose intensity (RDI)
time frame: 3-6 months
description: Chemotherapy completion rates will be assessed as relative dose intensity for each agent and then average relative dose intensity (ARDI), which considers all chemotherapy agents in a regimen. We will examine differences in RDI for each chemotherapy agent and the ARDI across all agents between the RT group and the UC group.
measure: Number of moderate and severe chemotherapy-associated toxicities
time frame: 3-6 months
description: Moderate and severe chemotherapy-associated toxicities will be assessed via a NCI PRO-CTCAE questionnaire, which is a patient-reported outcome measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials.
arm group label: Resistance training group
arm group type: Experimental
description: Participants randomized to the resistance training (RT) group will receive an in-person and telephone-based intervention to promote home-based resistance training. The exercise intervention will begin by the 3rd adjuvant chemotherapy visit and continue exercise through the completion of post-operative chemotherapy. Participants will work with an exercise professional with expertise working with oncology patients.
arm group label: Usual care group
arm group type: No Intervention
description: Participants randomized to the usual care (U) group will be instructed to refer to their physician regarding what forms of exercise are safe for them, given their medical history. The U group will be told to continue whatever exercise program they have been undertaking up to enrolling in the study, but not to increase exercise or begin weight-lifting over the period of study participation.
intervention type: Behavioral
intervention name: Resistance training
description: The intervention goal is for study participants to exercise with progressively higher weights for resistance training to achieve a 1-kg increase in lean body mass by the end of the intervention. During an in-person visit on the same day as a chemotherapy infusion session, exercise professionals will teach participants a series of exercises to be completed at home twice weekly throughout the intervention. Participants will also receive protein powder, which they will be instructed to consume with meals twice a day. During subsequent infusion sessions, the exercise professional will meet in-person with participants to evaluate their ability to increase weights, and adjust exercises appropriately. In between visits, the exercise professional will check-in with participants by phone.
arm group label: Resistance training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bette J Caan, DrPH
role: Principal Investigator
affiliation: Kaiser Permanente
last name: Kathryn H Schmitz, PhD, MPH
role: Principal Investigator
affiliation: Penn State Cancer Institute
last name: Jeffrey Meyerhardt, MD, MPH
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: No
provided document: 
provided document: 
provided document: 