This trial is active, not recruiting.

Conditions stage ii colon cancer, stage iii colon cancer
Treatment exercise
Phase phase 0
Sponsor Abramson Cancer Center of the University of Pennsylvania
Start date December 2015
End date January 2016
Trial size 39 participants
Trial identifier NCT02250053, UPCC 10214


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

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

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
Visceral adipose tissue and anthropometric measures at baseline and six-months;
time frame: 6 months
Fasting insulin measured at baseline and six-months;
time frame: six months
Circulating tumor cells measured at baseline and six-months.
time frame: six months

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study.
Principal investigator Kathryn Schmitz, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Abramson Cancer Center of the University of Pennsylvania.