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Exercise program tested to keep colon cancer at bay

NCT ID NCT00819208

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

889 people

The number who actually took part.

Started

Jun 2009

Finished

Mar 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Study site

    Lévis, Quebec, G6V 3Z1, Canada

  • Study site

    Montpellier, CEDEX 5, France

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1, Canada

  • Armidale Hospital

    Armidale, New South Wales, 2350, Australia

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200, Australia

  • Belfast City Hospital

    Belfast, Co. Antrim, BT9 7AB, United Kingdom

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756, United States

  • Exercise Medicine Center for Diabetes and Cancer

    Seoul, South Korea

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3, Canada

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Horizon Health Network

    Fredericton, New Brunswick, E3B 5N5, Canada

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2, Canada

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7, Canada

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • London Regional Cancer Program

    London, Ontario, N6A 5W9, Canada

  • Macarthur Cancer Therapy Centre - Campbelltown Hospital

    Campbelltown, 2560, Australia

  • Newcastle Private Hospital

    Newcastle, New South Wales, 2305, Australia

  • Niagara Health System

    St. Catharines, Ontario, L2S 0A9, Canada

  • North Coast Cancer Institute - Port Macquarie

    Port Macquarie, New South Wales, 2444, Australia

  • North Coast Cancer Institute Coffs Harbour

    Coffs Harbour, New South Wales, 2450, Australia

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6, Canada

  • Princess Alexandra

    Woolloongabba, Queensland, 4102, Australia

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick, E2L 4L2, Canada

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales, 2650, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029, Australia

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Sinai Health System

    Toronto, Ontario, M5G 1X5, Canada

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9, Canada

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076, Australia

  • Tamworth Hospital

    Tamworth, New South Wales, 2340, Australia

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8, Canada

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011, Australia

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • Toronto Rehab

    Toronto, Ontario, M4G 1R7, Canada

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1, Canada

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-1651, United States

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