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Completed

NCT Number: NCT02250053

Exercise and Colon Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • history of another primary invasive cancer (other than non-melanoma skin-cancer);
  • evidence of metastatic CC (i.e., TNM M1);
  • planning to receive any additional adjuvant chemotherapy;
  • pregnant or breast feeding;
  • unable to provide baseline blood sample;
  • cardiac conditions, including the following:
  • myocardial infarction or coronary revascularization procedure within prior 3 months;
  • uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);
  • high-risk or uncontrolled arrhythmias;
  • clinically significant valvular disease;
  • decompensated heart failure;
  • known aortic aneurysm;
  • 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).

Treatment and study plan

Exercise

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Visceral adipose tissue and anthropometric measures at baseline and six-months;

    Time frame: 6 months

  3. Fasting insulin measured at baseline and six-months;

    Time frame: six months

  4. Circulating tumor cells measured at baseline and six-months.

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2014
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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