Exercise program tested to keep colon cancer at bay
NCT ID NCT00819208
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a 3-year physical activity program could help prevent colon cancer from coming back in 889 patients who had surgery and chemotherapy for high-risk stage II or stage III colon cancer. Participants were randomly assigned to either the exercise program plus health education or health education alone. The main goal was to see if exercise improved disease-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- physical activity program
- What this could lead to
- If successful, this could show that a structured exercise program helps prevent colon cancer from coming back and improves survival.
- What could go wrong
- This is a completed trial, but the results may not show a clear benefit. Exercise adherence can vary, and the effect on cancer recurrence is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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889 people
The number who actually took part.
- Started
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Jun 2009
- Finished
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Mar 2026
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
DISEASE CHARACTERISTICS: * Completely resected histologically confirmed adenocarcinoma of the colon * High-risk stage II disease, including one of the following: * T4 lesions * Less than 12 sampled lymph nodes * Poorly differentiated histology * Stage III disease, defined as having at least one pathologically confirmed positive lymph node or one pathologically confirmed positive tumour deposit. * Synchronous primary colon cancer allowed * Adjuvant chemotherapy treatment for colon cancer with a 5-fluorouracil- based regimen received with an intent to provide a complete course of treatment. While one current standard is 24 weeks of treatment, patients who are pre-planned to receive a shorter duration of chemotherapy, including as part of a research study will also be permitted. The actual treatment received may be less than 24 weeks; participants must have received a minimum of one treatment cycle. * Chemotherapy must have been completed (i.e. last dose received) a minimum of 60 days and a maximum of 180 days prior to registration. * Carcinoembryonic antigen (CEA) ≤ 5 μg/L * Current physical activity levels do not meet the recommended guidelines (≥ 150 minutes of moderate-to-vigorous or ≥ 75 minutes of vigorous physical activity/week) as calculated using the Leisure Time Exercise Questionnaire (LTEQ) * Completion of chest x-ray or CT, and CT, MRI or ultrasound of abdomen within 60 days of registration; these imaging tests must not show evidence of metastatic or locally-recurrent colon cancer. * Complete one of the following: (a) at least 2 stages of the submaximal exercise test with an acceptable heart rate and blood pressure response as defined in Appendix XII or (b) the 6 minute walk test with an acceptable heart rate and blood pressure response * No rectal cancer PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute granulocyte count ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 100 g/L * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase \< 2.5 times ULN * ALT \< 2 times ULN * Not pregnant or planning to become pregnant within the next 3 years * Able (i.e., sufficiently fluent) and willing to effectively communicate with the physical activity consultant affiliated with the originating cancer center * Able (i.e., sufficiently fluent in English or French) and willing to complete the patient-reported outcome questionnaires, social determinants of exercise measurement, health economics, and physical activity questionnaires and logs * Able to complete the baseline exercise test * No significant comorbid conditions precluding participation in a physical activity program as determined by the investigator * Likely to participate in a physical activity program, as assessed by the investigator * No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, other solid tumors, Hodgkin lymphoma, or non-Hodgkin lymphoma curatively treated with no evidence of disease for \> 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy as a component of treatment for primary tumor * No concurrent treatment with additional chemotherapy or radiation * No concurrent treatment with any medications deemed by the investigator as likely to preclude participation in a physical activity program * No concurrent anticancer treatment including chemotherapy, biological, or targeted agents
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Study site
Lévis, Quebec, G6V 3Z1, Canada
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Study site
Montpellier, CEDEX 5, France
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Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
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Armidale Hospital
Armidale, New South Wales, 2350, Australia
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BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
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Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200, Australia
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Belfast City Hospital
Belfast, Co. Antrim, BT9 7AB, United Kingdom
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CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
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Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
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Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
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Dartmouth-Hitchcock
Lebanon, New Hampshire, 03756, United States
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Exercise Medicine Center for Diabetes and Cancer
Seoul, South Korea
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Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
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Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3, Canada
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Henry Ford Hospital
Detroit, Michigan, 48202, United States
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Horizon Health Network
Fredericton, New Brunswick, E3B 5N5, Canada
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Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
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Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
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Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
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London Regional Cancer Program
London, Ontario, N6A 5W9, Canada
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Macarthur Cancer Therapy Centre - Campbelltown Hospital
Campbelltown, 2560, Australia
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Newcastle Private Hospital
Newcastle, New South Wales, 2305, Australia
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Niagara Health System
St. Catharines, Ontario, L2S 0A9, Canada
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North Coast Cancer Institute - Port Macquarie
Port Macquarie, New South Wales, 2444, Australia
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North Coast Cancer Institute Coffs Harbour
Coffs Harbour, New South Wales, 2450, Australia
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Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
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Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
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Princess Alexandra
Woolloongabba, Queensland, 4102, Australia
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Regional Health Authority B, Zone 2
Saint John, New Brunswick, E2L 4L2, Canada
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Riverina Cancer Care Centre
Wagga Wagga, New South Wales, 2650, Australia
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Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
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Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
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Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
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Royal Perth Hospital
Perth, Western Australia, 6000, Australia
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Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
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Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
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Sinai Health System
Toronto, Ontario, M5G 1X5, Canada
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St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
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Stronach Regional Health Centre at Southlake
Newmarket, Ontario, L3Y 2P9, Canada
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Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
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Tamworth Hospital
Tamworth, New South Wales, 2340, Australia
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The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
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The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
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Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
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Toronto Rehab
Toronto, Ontario, M4G 1R7, Canada
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Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-1651, United States
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