Exercise and Colon Cancer

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02250053
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arm: 1
• Duration (Months): 1.5
• Patients Per Site Per Month: 29.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stage II Colon Cancer; Stage III Colon Cancer	Other: Exercise	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: exerciseexercise
• Primary Purpose: Treatment
• Official Title: The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: exercise aerobic exercise on soluble intercellular adhesion molecules	Other: Exercise

Outcome Measures

Primary Outcome Measures

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. [2 years]

Secondary Outcome Measures

1. Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study; [6 months]

2. Visceral adipose tissue and anthropometric measures at baseline and six-months; [6 months]

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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:

7. myocardial infarction or coronary revascularization procedure within prior 3 months;

8. uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);

9. high-risk or uncontrolled arrhythmias;

10. clinically significant valvular disease;

11. decompensated heart failure;

12. known aortic aneurysm;

13. 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Kathryn Schmitz, PhD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02250053
• Other Study ID Numbers: UPCC 10214
• First Posted: Sep 26, 2014
• Last Update Posted: Apr 9, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Abramson Cancer Center of the University of Pennsylvania: stage II and stage III colon cancer survivors, who have completed curative treatment i.e., surgical resection and chemotherapy for their colon cancer
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

No Results Posted as of Apr 9, 2020