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出境医 / 临床实验 / The Exercise And Colorectal Cancer Treatment Trial (EXACT)

The Exercise And Colorectal Cancer Treatment Trial (EXACT)

Study Description
Brief Summary:
This study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectal Cancer Behavioral: Moderate-Intensity Aerobic Exercise Behavioral: Wait-List Control Not Applicable

Detailed Description:
This randomized trial will examine the biological effects of 12-weeks of moderate-intensity aerobic exercise versus wait-list control in 60 subjects who have completed standard medical therapy for colorectal cancer. The primary objective is to determine if aerobic exercise can reduce systemic inflammation, quantified using plasma concentrations of high-sensitivity C-reactive protein, interleukin-6, and soluble tumor necrosis factor-alpha receptor two. The secondary objectives are to determine if exercise can reduce: 1) insulin resistance quantified using an oral glucose tolerance test, and; 2) circulating tumor cells quantified using a microfluidic antibody-mediated capture platform. The exploratory objective is to determine if exercise can improve mitochondrial respiration rates and fatty acid oxidation.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Exercise And Colorectal Cancer Treatment (EXACT) Trial
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Aerobic Exercise
Moderate-intensity aerobic exercise
 Behavioral: Moderate-Intensity Aerobic Exercise
The exercise intervention will consist of moderate-intensity (50-70% age-predicted maximum heart rate) treadmill walking. All exercise sessions will begin with a five-minute warm up of slow walking, 30-60 minutes of moderate-intensity walking, and a five-minute cool down of slow walking.
Sham Comparator: Control
Wait-list control
 Behavioral: Wait-List Control
Participants randomized into the wait-list control group are asked to maintain their pre-study levels of physical activity and follow the recommendations provided by their physician.
Outcome Measures
Primary Outcome Measures :
  1. High Sensitivity C-Reactive Protein [ Time Frame: Baseline, 12 weeks ]
    Concentration of high-sensitivity C-reactive protein (mg/L)

  2. Interleukin-6 [ Time Frame: Baseline, 12 weeks ]
    Concentration of interleukin-6 (pg/mL)


Secondary Outcome Measures :
  1. Soluble Tumor Necrosis Factor-Alpha Receptor Two [ Time Frame: Baseline, 12 weeks ]
    Concentration of soluble tumor necrosis factor-alpha receptor two (pg/mL)

  2. Insulin Resistance [ Time Frame: Baseline, 12 weeks ]
    Oral Glucose Tolerance Test (2 hour AUC)

  3. Circulating Tumor Cells [ Time Frame: Baseline, 12 weeks ]
    Concentration of circulating tumor cells (cells per mL whole blood)

  4. Tumor Fraction [ Time Frame: Baseline, 12 weeks ]
    Proportion of Circulating Tumor DNA (relative to all cell-free DNA)


Other Outcome Measures:
  1. Mitochondrial Respiration Rate [ Time Frame: Baseline, 12 weeks ]
    Respiration rate (pmol O2/sec/million cells)

  2. Fatty Acid Oxidation [ Time Frame: Baseline, 12 weeks ]
    Oxidation rate (mmol/mg/min)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Histologically-confirmed stage I-III colorectal cancer
  • Completed surgical resection
  • Completed chemotherapy (if applicable)
  • Completed radiotherapy (if applicable)
  • Self-report, on average over the past one-month, less than or 90 minutes per week of moderate-intensity or vigorous-intensity physical activity
  • Provide written approval by physician or other qualified healthcare provider
  • No planned major surgery during the study period (including colostomy reversal; chemotherapy infusion port removal is permitted)
  • Readiness to exercise [as determined by a modified version the Physical Activity Readiness Questionnaire (PAR-Q)
  • Allow the collection and storage of specimens and data for future use 1.10 Willing to be randomized

Exclusion Criteria:

  • Evidence of metastatic colon cancer
  • Concurrently actively treated other cancer (except non-melanoma skin cancer or in situ cancers)
  • Currently enrolled in another clinical trial of weight loss, physical activity, or dietary intervention
  • Current body mass greater than or equal to 181 kg
  • Unable to provide a baseline fasting blood sample
  • Unable or unwilling to give informed consent
  • Unable or unwilling to be randomized
  • Or any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (as determined by the investigative team)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Kaylee T Woodard 225-763-2814 kaylee.woodard@pbrc.ed

Locations
Layout table for location information
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Kaylee T. Woodard       kaylee.woodard@pbrc.edu   
Sponsors and Collaborators
Pennington Biomedical Research Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Justin C Brown, Ph.D. Pennington Biomedical Research Center
Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date November 17, 2020
Actual Study Start Date  ICMJE August 16, 2019
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • High Sensitivity C-Reactive Protein [ Time Frame: Baseline, 12 weeks ]
    Concentration of high-sensitivity C-reactive protein (mg/L)
  • Interleukin-6 [ Time Frame: Baseline, 12 weeks ]
    Concentration of interleukin-6 (pg/mL)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03975491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Soluble Tumor Necrosis Factor-Alpha Receptor Two [ Time Frame: Baseline, 12 weeks ]
    Concentration of soluble tumor necrosis factor-alpha receptor two (pg/mL)
  • Insulin Resistance [ Time Frame: Baseline, 12 weeks ]
    Oral Glucose Tolerance Test (2 hour AUC)
  • Circulating Tumor Cells [ Time Frame: Baseline, 12 weeks ]
    Concentration of circulating tumor cells (cells per mL whole blood)
  • Tumor Fraction [ Time Frame: Baseline, 12 weeks ]
    Proportion of Circulating Tumor DNA (relative to all cell-free DNA)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Soluble Tumor Necrosis Factor-Alpha Receptor Two [ Time Frame: Baseline, 12 weeks ]
    Concentration of soluble tumor necrosis factor-alpha receptor two (pg/mL)
  • Insulin Resistance [ Time Frame: Baseline, 12 weeks ]
    Oral Glucose Tolerance Test (2 hour AUC)
  • Circulating Tumor Cells [ Time Frame: Baseline, 12 weeks ]
    Concentration of circulating tumor cells (cells per mL whole blood)
Current Other Pre-specified Outcome Measures
 (submitted: June 4, 2019)
  • Mitochondrial Respiration Rate [ Time Frame: Baseline, 12 weeks ]
    Respiration rate (pmol O2/sec/million cells)
  • Fatty Acid Oxidation [ Time Frame: Baseline, 12 weeks ]
    Oxidation rate (mmol/mg/min)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Exercise And Colorectal Cancer Treatment Trial
Official Title  ICMJE The Exercise And Colorectal Cancer Treatment (EXACT) Trial
Brief Summary This study will examine the biologic processes through which exercise may prevent disease recurrence in patients who have completed treatment for colorectal cancer.
Detailed Description This randomized trial will examine the biological effects of 12-weeks of moderate-intensity aerobic exercise versus wait-list control in 60 subjects who have completed standard medical therapy for colorectal cancer. The primary objective is to determine if aerobic exercise can reduce systemic inflammation, quantified using plasma concentrations of high-sensitivity C-reactive protein, interleukin-6, and soluble tumor necrosis factor-alpha receptor two. The secondary objectives are to determine if exercise can reduce: 1) insulin resistance quantified using an oral glucose tolerance test, and; 2) circulating tumor cells quantified using a microfluidic antibody-mediated capture platform. The exploratory objective is to determine if exercise can improve mitochondrial respiration rates and fatty acid oxidation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Colon Cancer
  • Rectal Cancer
Intervention  ICMJE
  • Behavioral: Moderate-Intensity Aerobic Exercise
    The exercise intervention will consist of moderate-intensity (50-70% age-predicted maximum heart rate) treadmill walking. All exercise sessions will begin with a five-minute warm up of slow walking, 30-60 minutes of moderate-intensity walking, and a five-minute cool down of slow walking.
  • Behavioral: Wait-List Control
    Participants randomized into the wait-list control group are asked to maintain their pre-study levels of physical activity and follow the recommendations provided by their physician.
Study Arms  ICMJE
  • Experimental: Aerobic Exercise
    Moderate-intensity aerobic exercise
    Intervention: Behavioral: Moderate-Intensity Aerobic Exercise
  • Sham Comparator: Control
    Wait-list control
    Intervention: Behavioral: Wait-List Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥18 years
  • Histologically-confirmed stage I-III colorectal cancer
  • Completed surgical resection
  • Completed chemotherapy (if applicable)
  • Completed radiotherapy (if applicable)
  • Self-report, on average over the past one-month, less than or 90 minutes per week of moderate-intensity or vigorous-intensity physical activity
  • Provide written approval by physician or other qualified healthcare provider
  • No planned major surgery during the study period (including colostomy reversal; chemotherapy infusion port removal is permitted)
  • Readiness to exercise [as determined by a modified version the Physical Activity Readiness Questionnaire (PAR-Q)
  • Allow the collection and storage of specimens and data for future use 1.10 Willing to be randomized

Exclusion Criteria:

  • Evidence of metastatic colon cancer
  • Concurrently actively treated other cancer (except non-melanoma skin cancer or in situ cancers)
  • Currently enrolled in another clinical trial of weight loss, physical activity, or dietary intervention
  • Current body mass greater than or equal to 181 kg
  • Unable to provide a baseline fasting blood sample
  • Unable or unwilling to give informed consent
  • Unable or unwilling to be randomized
  • Or any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (as determined by the investigative team)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kaylee T Woodard 225-763-2814 kaylee.woodard@pbrc.ed
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975491
Other Study ID Numbers  ICMJE 2019-009
R00CA218603 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Upon reporting and publication of the primary, secondary, and exploratory study outcomes de-identified individual participant data will be released to investigators.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: After reporting and publication of the primary, secondary, and exploratory study outcomes is complete.
Access Criteria: Data will be shared according to the principles outlined by Tudur Smith et al in BMC Medicine 2015.
Responsible Party Justin Brown, Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Justin C Brown, Ph.D. Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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