Physical Activity and Education for Colorectal Cancer

(CHALLENGE Trial)

Not currently recruiting at 51 trial locations

Overseen By Autumn McRee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Cancer Trials Group

Must not be taking: Anticancer treatments

Disqualifiers: Rectal cancer, Other malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 48

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether a physical activity program, combined with health education materials, is more effective than the materials alone for individuals who have undergone surgery and chemotherapy for colon cancer. The focus is on enhancing physical fitness, mental well-being, and overall quality of life, while also exploring whether these improvements can lower the risk of cancer recurrence. Participants should have completed treatment for high-risk stage II or stage III colon cancer and not currently meet recommended physical activity levels. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could improve recovery and quality of life after cancer treatment.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any concurrent anticancer treatment, including chemotherapy, biological, or targeted agents. You also cannot take medications that the investigator thinks might prevent you from participating in the physical activity program.

What prior data suggests that this physical activity program and health education materials are safe for patients who have undergone colon cancer treatment?

Research has shown that physical activity is generally safe for people with colon cancer. In several studies, exercising after chemotherapy helped people live longer without cancer returning. For example, one study found that patients who exercised after chemotherapy had a 28% lower risk of cancer recurrence. Another study demonstrated that being active during and after treatment reduced the chance of cancer returning.

These findings suggest that exercise is well-tolerated and may improve outcomes for colon cancer survivors. While exercise is not a typical drug treatment, it is safe for most people and may offer additional health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of combining physical activity with health education for managing colorectal cancer. Unlike standard treatments that primarily involve surgery, chemotherapy, and radiation, this trial emphasizes lifestyle changes that could enhance overall well-being and potentially improve outcomes for patients. By focusing on physical activity and personalized education, researchers hope to uncover new ways to support patients in their recovery journey, offering a complementary approach that empowers individuals to take an active role in their health.

What evidence suggests that this trial's treatments could be effective for colon cancer?

Research shows that joining a physical activity program can greatly benefit individuals treated for colon cancer. In this trial, one group will participate in a Physical Activity Program while receiving General Health Education Materials. Studies have found that organized exercise programs reduce the chance of cancer returning by 28% compared to only receiving health education materials, which is the focus of the other group in this trial. Regular exercise can also increase the chances of staying cancer-free, with one study reporting an 80.3% survival rate after five years for those who exercised regularly. Additionally, exercise enhances quality of life and physical fitness for colorectal cancer survivors. Overall, staying active after treatment plays a crucial role in preventing cancer recurrence and improving health. ^{6 7 8 9 10}

Who Is on the Research Team?

Janette Vardy, PhD, FRACP

Principal Investigator

Sydney Cancer Centre at Concord Repatriation General Hospital

Kerry Courneya, PhD

Principal Investigator

University of Alberta

Christopher Booth, MD

Principal Investigator

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

I am not currently receiving any other chemotherapy or radiation treatments.

I am not currently on any cancer treatments like chemotherapy.

I have had radiotherapy for my initial cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intensive Intervention

Participants undergo 12 mandatory biweekly face-to-face behavior support sessions combined with 12 mandatory supervised physical activity sessions to increase their physical activity goal by 10 MET hours/week.

6 months

12 visits (in-person)

Reduced Intervention

Participants undergo 12 mandatory biweekly face-to-face or telephone behavior support sessions combined with 12 recommended supervised physical activity sessions to increase their physical activity goal by 20 MET hours/week.

6 months

12 visits (in-person or virtual)

Minimal Intervention

Participants undergo mandatory monthly face-to-face or telephone behavior support sessions combined with recommended supervised physical activity sessions to increase their physical activity goal to a maximum total of 27 MET hours/week.

24 months

24 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-10 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Materials
• Physical Activity Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Physical Activity Program + General Health Education Materials Active Control 9 Interventions

Intervention Arm

Group II: General Health Education Materials Active Control 7 Interventions

Control Arm

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Queen's University, Belfast

Collaborator

Trials

179

Recruited

142,000+

Survivorship Research Group

Collaborator

Trials

1

Recruited

890+

Published Research Related to This Trial

Colorectal cancer mortality has decreased over the past 20 years, largely due to better screening and treatment options.

Incorporating physical activity into the management plan for colorectal cancer survivors is crucial, as it enhances quality of life, slows functional decline, and reduces overall mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of physical activity on survival in patients with colorectal cancer. DeTroye, A., Christner, M., Eganhouse, D., et al.[2018]

In a study of 47 colorectal cancer patients, factors such as knee extensor muscle strength, fatigue severity, and quality of life significantly influenced physical activity levels, explaining 43% of the variance in activity.

Moderate correlations were found between physical activity and muscle strength, balance, and fatigue, indicating that improving these factors could enhance physical activity and overall well-being in CRC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing physical activity in patients with colorectal cancer. Kucukvardar, D., Karadibak, D., Ozsoy, I., et al.[2021]

Health professionals often missed opportunities to promote physical activity (PA) during the chemotherapy treatment of colorectal cancer patients, despite its importance for managing side effects and maintaining function.

Post-treatment, there was a noticeable increase in PA promotion by health professionals, indicating a need for better integration of PA support throughout the entire cancer treatment journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities for physical activity management at key points throughout the chemotherapy pathway for colorectal survivors: an observational interview study. Veal, I., Peat, N., Jones, GD., et al.[2022]

Physical activity is beneficial for colorectal cancer survivors, as it can reduce the risk of colon cancer recurrence and improve overall quality of life and cardiovascular health, based on a review of existing data.

While the evidence for rectal cancer survivors is less strong, physical activity still shows positive effects on quality of life and health outcomes, potentially through mechanisms involving inflammation and insulin-like growth factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer survivorship: movement matters. Denlinger, CS., Engstrom, PF.[2021]

A six-month mixed exercise program significantly improved flexibility, lower limb strength, and aerobic capacity in patients recovering from colorectal cancer surgery, compared to a control group that did not exercise.

Patients in the exercise group also experienced a notable reduction in body fat and an increase in cell mass, highlighting the potential of exercise to enhance physical recovery after surgery for colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Results of an Exercise Program After Laparoscopic Resective Colorectal Cancer Surgery in Non-Metastatic Adenocarcinoma: A Pilot Study of a Randomized Control Trial. Mascherini, G., Ringressi, MN., Castizo-Olier, J., et al.[2020]

Only 25.60% of colorectal cancer survivors in the study met the physical activity guidelines, indicating a need for improved activity levels among these patients.

Factors such as fatigue, body image, depression, and self-efficacy were found to be closely linked to physical activity levels, suggesting that addressing these issues could help increase physical activity in colorectal cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of Physical Activity in Colorectal Cancer Patients Based on Health Promotion Model. Kang, DQ., Li, Y., Chen, ZQ., et al.[2021]

A ten-step development process was used to create a safe and effective inpatient exercise program for colorectal cancer patients recovering from surgery, which included systematic reviews and expert discussions.

The exercise program significantly reduced the length of hospital stays and the time to flatus, indicating improved recovery outcomes for patients after colectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development process of an evidence-based exercise program for post-operative colorectal cancer patients. An, KY., In Yang, H., Kang, DW., et al.[2020]

Physical inactivity is linked to 13-14% of colon cancer cases, suggesting that being active may be more important than family history in reducing risk.

While there is some evidence that physical activity can improve outcomes after a colorectal cancer diagnosis, the specific effects of exercise interventions on cancer risk and prognosis remain unclear, and no optimal exercise regimen has been established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity before and after diagnosis of colorectal cancer: disease risk, clinical outcomes, response pathways and biomarkers. Harriss, DJ., Cable, NT., George, K., et al.[2021]

A review of 19 cohort studies found that physically active males have a significantly reduced risk of colon cancer, with risk ratios of 0.79 for occupational activities and 0.78 for recreational activities.

For women, only recreational physical activities were associated with a protective effect against colon cancer (RR = 0.71), while no significant protection was observed for rectal cancer in either sex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the association of physical activity with reduced risk of colorectal cancer. Samad, AK., Taylor, RS., Marshall, T., et al.[2006]

Citations

1. asco.org asco.org/about-asco/press-center/news-releases/movement-medicine-structured-exercise-program-challenge

Structured Exercise Program May Lower Risk of Cancer ... Patients in the structured exercise program had a 28% lower risk of recurrent or new cancers developing than patients who only received health ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8560161/

Physical Activity Interventions for Colorectal Cancer Survivors We provided evidence that PA interventions were effective in improving disease-specific quality of life, PA level, and maximum amount of oxygen.

3. bgi.com bgi.com/global/news/exercise-proves-powerful-in-preventing-colon-cancer

Exercise Proves Powerful in Preventing Colon Cancer Over nearly eight years, the results were striking: disease-free survival at five years was 80.3% in the exercise group, compared to 73.9% in ...

4. cancerci.biomedcentral.com cancerci.biomedcentral.com/articles/10.1186/s12935-025-03872-1

The role of physical activity and epigenetic changes in ... Regular and consistent physical activity significantly reduces the risk of colorectal cancer (CRC) by approximately 24% in men and 23% in women.

5. nature.com nature.com/articles/s41598-025-88067-4

A cross-sectional study on the association between ... Low physical activity increases the risk of colon cancer, while moderate to high-intensity physical activity can reduce the risk of colon cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6522766/

Effect of exercise on colorectal cancer prevention and treatment In a meta-analysis study involving 21 studies, the association between physical activity and colon cancer did not differ with the anatomical location[14].

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2502760

Structured Exercise after Adjuvant Chemotherapy for Colon ... A 3-year structured exercise program initiated soon after adjuvant chemotherapy for colon cancer resulted in significantly longer disease-free survival.

8. aicr.org aicr.org/resources/blog/new-study-shows-benefits-of-physical-activity-for-colon-cancer-survivors/

New Study Shows Benefits of Physical Activity for Colon ... Colon cancer survivors who took part in a three-year structured exercise program had a 28 percent lower risk of cancer recurrence or a second ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8508146/

Physical Activity after Colorectal Cancer Diagnosis and ... The results indicate that satisfying the recommended level of activity is associated with a lowered risk of mortality in colorectal cancer patients, ...

10. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35727

The association of physical activity with survival in colon ... Among 1696 patients with stage III colon cancer, physical activity during and after chemotherapy lowered the risk of tumor recurrence in the ...