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The Exercise And Colorectal Cancer Treatment Trial (EXACT)

Primary Purpose

Colon Cancer, Rectal Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate-Intensity Aerobic Exercise
Wait-List Control
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Aerobic Exercise

Control

Arm Description

Moderate-intensity aerobic exercise

Wait-list control

Outcomes

Primary Outcome Measures

High Sensitivity C-Reactive Protein
Concentration of high-sensitivity C-reactive protein (mg/L)
Interleukin-6
Concentration of interleukin-6 (pg/mL)

Secondary Outcome Measures

Soluble Tumor Necrosis Factor-Alpha Receptor Two
Concentration of soluble tumor necrosis factor-alpha receptor two (pg/mL)
Insulin Resistance
Oral Glucose Tolerance Test (2 hour AUC)
Circulating Tumor Cells
Concentration of circulating tumor cells (cells per mL whole blood)
Tumor Fraction
Proportion of Circulating Tumor DNA (relative to all cell-free DNA)

Full Information

First Posted
June 4, 2019
Last Updated
June 9, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03975491
Brief Title
The Exercise And Colorectal Cancer Treatment Trial
Acronym
EXACT
Official Title
The Exercise And Colorectal Cancer Treatment (EXACT) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
May 16, 2023 (Actual)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise
Arm Type
Experimental
Arm Description
Moderate-intensity aerobic exercise
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Wait-list control
Intervention Type
Behavioral
Intervention Name(s)
Moderate-Intensity Aerobic Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait-List Control
Intervention Description
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 Measure Information:
Title
High Sensitivity C-Reactive Protein
Description
Concentration of high-sensitivity C-reactive protein (mg/L)
Time Frame
Baseline, 12 weeks
Title
Interleukin-6
Description
Concentration of interleukin-6 (pg/mL)
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Soluble Tumor Necrosis Factor-Alpha Receptor Two
Description
Concentration of soluble tumor necrosis factor-alpha receptor two (pg/mL)
Time Frame
Baseline, 12 weeks
Title
Insulin Resistance
Description
Oral Glucose Tolerance Test (2 hour AUC)
Time Frame
Baseline, 12 weeks
Title
Circulating Tumor Cells
Description
Concentration of circulating tumor cells (cells per mL whole blood)
Time Frame
Baseline, 12 weeks
Title
Tumor Fraction
Description
Proportion of Circulating Tumor DNA (relative to all cell-free DNA)
Time Frame
Baseline, 12 weeks
Other Pre-specified Outcome Measures:
Title
Mitochondrial Respiration Rate
Description
Respiration rate (pmol O2/sec/million cells)
Time Frame
Baseline, 12 weeks
Title
Fatty Acid Oxidation
Description
Oxidation rate (mmol/mg/min)
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin C Brown, Ph.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon reporting and publication of the primary, secondary, and exploratory study outcomes de-identified individual participant data will be released to investigators.
IPD Sharing Time Frame
After reporting and publication of the primary, secondary, and exploratory study outcomes is complete.
IPD Sharing Access Criteria
Data will be shared according to the principles outlined by Tudur Smith et al in BMC Medicine 2015.

Learn more about this trial

The Exercise And Colorectal Cancer Treatment Trial

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