The Exercise And Colorectal Cancer Treatment Trial (EXACT)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    60
  • sponsor
    Pennington Biomedical Research Center
Updated on 24 March 2022
aerobic exercise
stage iii colon cancer

Summary

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

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.

Details
Condition Colon Cancer, Rectal Cancer
Treatment Wait-list control, Moderate-Intensity Aerobic Exercise
Clinical Study IdentifierNCT03975491
SponsorPennington Biomedical Research Center
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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