Exercise and Colon Cancer

Not Applicable

Completed

• Conditions: Stage III Colon Cancer; Stage II Colon Cancer
• Interventions: Other: Exercise

• Registration Number: NCT02250053
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-26
• Study Start: 2015-12
• Primary Completion: 2016-01
• Study Completion: 2016-01-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
exercise	Exercise	aerobic exercise on soluble intercellular adhesion molecules

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States