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The Exercise And Colon Cancer Treatment Trial (EXACT)

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ClinicalTrials.gov Identifier: NCT03975491
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Justin Brown, Pennington Biomedical Research Center

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

Condition or disease Intervention/treatment Phase
Colon 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 colon 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.

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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 Colon Cancer Treatment (EXACT) Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


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.




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)


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)



Information from the National Library of Medicine

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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 III colon cancer
  • Completed surgical resection within 1-24 months
  • Completed chemotherapy (if applicable) within 1-24 months
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975491


Contacts
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Contact: Kaylee T Woodard 225-763-2814 kaylee.woodard@pbrc.ed

Sponsors and Collaborators
Pennington Biomedical Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Justin C Brown, Ph.D. Pennington Biomedical Research Center

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Responsible Party: Justin Brown, Director, Cancer Metabolism, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03975491     History of Changes
Other Study ID Numbers: 2019-009
R00CA218603 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
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
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases