Exercise and Colon Cancer

April 7, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study

Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of The University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. histologically confirmed TNM stage II-III CC;
  2. completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study;
  3. ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire;
  4. age ≥18 years;
  5. written physician approval;
  6. no additional surgery planned within the 6-month intervention (including colostomy reversal);
  7. ability to walk unaided for 6-minutes;
  8. no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless physician approves participation with specific knowledge of this contraindication.

Exclusion Criteria:

  1. history of another primary invasive cancer (other than non-melanoma skin-cancer);
  2. evidence of metastatic CC (i.e., TNM M1);
  3. planning to receive any additional adjuvant chemotherapy;
  4. pregnant or breast feeding;
  5. unable to provide baseline blood sample;

  6. cardiac conditions, including the following:

    1. myocardial infarction or coronary revascularization procedure within prior 3 months;
    2. uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);
    3. high-risk or uncontrolled arrhythmias;
    4. clinically significant valvular disease;
    5. decompensated heart failure;
    6. known aortic aneurysm;
  7. any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (determined by the investigative team).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercise
aerobic exercise on soluble intercellular adhesion molecules
Other: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;
Time Frame: 6 months
6 months
Visceral adipose tissue and anthropometric measures at baseline and six-months;
Time Frame: 6 months
6 months
Fasting insulin measured at baseline and six-months;
Time Frame: six months
six months
Circulating tumor cells measured at baseline and six-months.
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 15, 2016

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 10214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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