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Exercise and Colon Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02250053
Enrollment
44
Registered
2014-09-26
Start date
2015-12-31
Completion date
2016-01-15
Last updated
2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage II Colon Cancer, Stage III Colon Cancer

Keywords

stage II and stage III colon cancer survivors, who have completed curative treatment i.e., surgical resection and chemotherapy for their colon cancer

Brief summary

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.

Interventions

OTHERExercise

Sponsors

Abramson Cancer Center at Penn Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Intervention model description

exercise

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime 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.2 years

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026