Clinical trial NCT02250053: Exercise and Colon Cancer
Official title: The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: exercise
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;
timeFrame: 6 months
measure: Visceral adipose tissue and anthropometric measures at baseline and six-months;
timeFrame: 6 months
measure: Fasting insulin measured at baseline and six-months;
timeFrame: six months
measure: Circulating tumor cells measured at baseline and six-months.
timeFrame: six months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Kathryn Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: