Exercise and Colon Cancer
Primary Purpose
Stage II Colon Cancer, Stage III Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stage II Colon Cancer focused on measuring stage II and stage III colon cancer survivors, who have completed curative treatment i.e., surgical resection and chemotherapy for their colon cancer
Eligibility Criteria
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).
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exercise
Arm Description
aerobic exercise on soluble intercellular adhesion molecules
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;
Visceral adipose tissue and anthropometric measures at baseline and six-months;
Fasting insulin measured at baseline and six-months;
Circulating tumor cells measured at baseline and six-months.
Full Information
NCT ID
NCT02250053
First Posted
September 22, 2014
Last Updated
April 7, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02250053
Brief Title
Exercise and Colon Cancer
Official Title
The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
exercise
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise
Arm Type
Experimental
Arm Description
aerobic exercise on soluble intercellular adhesion molecules
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Visceral adipose tissue and anthropometric measures at baseline and six-months;
Time Frame
6 months
Title
Fasting insulin measured at baseline and six-months;
Time Frame
six months
Title
Circulating tumor cells measured at baseline and six-months.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Schmitz, PhD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Exercise and Colon Cancer
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