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Physical Activity and Education for Colorectal Cancer (CHALLENGE Trial)
N/A
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
T4 lesions
Stage III disease, defined as having at least one pathologically confirmed positive lymph node or one pathologically confirmed positive tumour deposit.
Must not have
Concurrent treatment with additional chemotherapy or radiation
Concurrent anticancer treatment including chemotherapy, biological, or targeted agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Summary
This trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.
Who is the study for?
This trial is for patients who've completed certain chemotherapy for high-risk stage II or III colon cancer within the last 60-180 days. They should be able to communicate, complete questionnaires and exercise tests, not meet current physical activity guidelines, and have no evidence of recurring cancer. Pregnant individuals or those planning pregnancy in the next 3 years are excluded.Check my eligibility
What is being tested?
The study compares two approaches: one group receives health education materials plus a physical activity program designed to increase free time physical activity; another group gets only the health education materials. The goal is to see which method better prevents cancer recurrence and improves fitness and well-being.See study design
What are the potential side effects?
Since this trial involves exercise and educational interventions rather than drugs, side effects may include typical exercise-related issues such as muscle soreness or strain. Psychological discomfort could also occur due to changes in lifestyle or from discussing health-related topics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is at stage T4.
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My cancer is at stage III, confirmed by a positive lymph node or tumor deposit.
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I finished my chemotherapy between 2 to 6 months ago.
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I am fully active or can carry out light work.
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I completed a 5-fluorouracil-based chemotherapy for colon cancer.
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My cancer is high-risk stage II with specific features.
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I do not have rectal cancer.
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My cancer is stage III with at least one confirmed positive lymph node.
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My cancer is of a type that grows and spreads quickly.
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My colon cancer was surgically removed and confirmed by a lab test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently receiving any other chemotherapy or radiation treatments.
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I am not currently on any cancer treatments like chemotherapy.
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I have had radiotherapy for my initial cancer.
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I am not on medications that would stop me from joining a physical activity program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-free survival
Secondary outcome measures
Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue
Economic evaluations including cost-effective analysis and cost utility analysis
Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function)
+5 moreTrial Design
2Treatment groups
Active Control
Group I: Physical Activity Program + General Health Education MaterialsActive Control9 Interventions
Intervention Arm
Group II: General Health Education MaterialsActive Control7 Interventions
Control Arm
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
127 Previous Clinical Trials
67,415 Total Patients Enrolled
Queen's University, BelfastOTHER
167 Previous Clinical Trials
134,530 Total Patients Enrolled
Survivorship Research GroupUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count is at least 100,000 per cubic millimeter.My cancer is at stage T4.My cancer is at stage III, confirmed by a positive lymph node or tumor deposit.I am not currently receiving any other chemotherapy or radiation treatments.I finished chemotherapy between 2 to 6 months ago.Your carcinoembryonic antigen (CEA) level is less than or equal to 5 micrograms per liter.Your hemoglobin level is at least 100 grams per liter.Your kidney function, as measured by a blood test for creatinine, is not more than 1.5 times the upper limit of normal.You are probably going to take part in a program that involves physical activity.I have no cancer history, except for certain types treated over 5 years ago.You do not exercise enough based on the recommended guidelines.I finished my chemotherapy between 2 to 6 months ago.My recent scans show no signs of my colon cancer spreading or returning.I am fully active or can carry out light work.I have received at least one cycle of chemotherapy for colon cancer.You are not currently meeting the recommended guidelines for physical activity.I completed a 5-fluorouracil-based chemotherapy for colon cancer.Your body has enough infection-fighting white blood cells.My cancer is high-risk stage II with specific features.You had fewer than 12 lymph nodes removed for testing.You do not exercise enough based on the Leisure Time Exercise Questionnaire.I am not currently on any cancer treatments like chemotherapy.I have another primary cancer in my colon.I have had radiotherapy for my initial cancer.I am not on medications that would stop me from joining a physical activity program.I do not have rectal cancer.Your alkaline phosphatase level is not more than 2.5 times the upper limit of normal.You need to pass a physical test that measures how well your heart and blood pressure respond to exercise.You don't have any health conditions that would prevent you from taking part in physical activities.My cancer is stage III with at least one confirmed positive lymph node.Your total bilirubin level is not more than 1.5 times the upper limit of normal.My cancer is of a type that grows and spreads quickly.My colon cancer was surgically removed and confirmed by a lab test.Your liver enzyme levels are not more than two times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Physical Activity Program + General Health Education Materials
- Group 2: General Health Education Materials
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT00819208 — N/A
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