Exercise and Colon Cancer

Stage III Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250053
• Other study ID #: UPCC 10214
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: January 15, 2016

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 15, 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colonic Neoplasms
• Stage II Colon Cancer
• Stage III Colon Cancer

Intervention

Other:
• Exercise

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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