Exercise Intervention for Colorectal Cancer Survivors

Overseen By Heather Greenlee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Must not be taking: Antibiotics, Antifungals, Antiparasitics

Disqualifiers: Ileostomy, Colostomy, Inflammatory bowel diseases, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial evaluates the effects a moderate-to-vigorous exercise intervention has on the bacterial make-up of the gastrointestinal tract (gut microbiota) in survivors of stage II-III colorectal cancer (CRC). Data shows that the gut microbiota composition and function may be drivers of CRC. High levels of exercise are associated with improved CRC prognosis and survival. While data suggests that exercise has the potential to influence gut microbiota composition and function, it is not known whether these effects contribute to improved CRC prognosis. This clinical trial evaluates the effects an exercise intervention has on gut microbiota and how these effects relate to CRC progression and patient-reported outcomes.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude participants who have used antibiotics, antifungals, or antiparasitics in the past 6 months.

What data supports the effectiveness of the treatment Exercise Intervention for Colorectal Cancer Survivors?

Research shows that physical activity can lower the risk of colon cancer coming back and improve overall health and quality of life for survivors. Exercise helps with fitness and body composition, which are important for better health outcomes after cancer treatment. ^{1 2 3 4 5}

Is exercise intervention safe for colorectal cancer survivors?

Exercise interventions, including aerobic and resistance training, have been shown to be safe for colorectal cancer survivors. Studies have reported high adherence rates and positive participant evaluations, with no significant safety concerns noted. ^{4 5 6 7 8}

How does the exercise intervention treatment for colorectal cancer survivors differ from other treatments?

The exercise intervention for colorectal cancer survivors is unique because it focuses on improving physical fitness and quality of life through regular physical activity, which can reduce cancer recurrence risk and improve overall health, unlike traditional treatments that primarily target cancer cells directly. ^{4 5 8 9 10}

Research Team

Heather Greenlee

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

This trial is for stage II-III colorectal cancer survivors aged 18-70, with a BMI of 18.5-30, not currently smoking or pregnant, and within 60 days to 3 years post-cancer treatment. Participants must be able to exercise, have smartphone access, and commit to attending the study sessions.

Inclusion Criteria

I had stage II-III colon cancer but currently have no signs of it spreading.

Willingness to participate in all study activities

No comorbid or physical limitations that would limit participation at the discretion of the treating provider

Exclusion Criteria

My BMI is either below 18.5 or above 30.

I have not taken antibiotics, antifungals, or antiparasitics in the last 6 months.

I am not pregnant, breastfeeding, nor planning to become pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a supervised exercise intervention or health-related information over 8 weeks. Blood samples are collected at baseline and week 8.

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for retention, adherence, and acceptability of the intervention.

4 weeks

Treatment Details

Interventions

• Exercise Intervention

Trial Overview The trial studies how an exercise program affects gut bacteria in colorectal cancer survivors. It involves moderate-to-vigorous workouts at a research center, along with health education and monitoring through interviews and questionnaires.

Participant Groups

Group I: Arm A (exercise intervention) Experimental Treatment 4 Interventions

Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8.

Group II: Arm B (waitlist control) Active Control 5 Interventions

Patients receive health-related information for 8 weeks on study. Patients are then offered a session of supervised exercise followed by 7 weeks of tele-coaching sessions. Patients also undergo collection of blood samples at baseline and week 8.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

High-intensity interval exercise (HIIE) significantly improves cardiorespiratory fitness (V˙o2peak) and reduces fat mass more effectively than moderate-intensity continuous exercise (MICE) in colorectal cancer survivors over an 8-week period.

Even after reducing the frequency of HIIE sessions, participants maintained their fitness gains and fat loss, indicating that HIIE can provide lasting benefits with less training compared to traditional exercise guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiorespiratory Fitness and Body Composition Responses to Different Intensities and Frequencies of Exercise Training in Colorectal Cancer Survivors. Devin, JL., Jenkins, DG., Sax, AT., et al.[2022]

In the CAN-HOPE trial involving 69 colorectal cancer survivors, participants reported not meeting the minimum exercise guidelines in 39.2% of the weeks, highlighting significant challenges in adherence to exercise recommendations.

The most common barriers to exercise included lack of time, treatment side effects, and fatigue, which accounted for 70% to 80% of missed exercise weeks, suggesting targeted interventions could help improve adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A longitudinal study of exercise barriers in colorectal cancer survivors participating in a randomized controlled trial. Courneya, KS., Friedenreich, CM., Quinney, HA., et al.[2022]

A home-based exercise program significantly improved quality of life (QOL) and emotional well-being in colorectal cancer survivors, with notable improvements in specific QOL sub-domains.

Participants in the exercise group increased their physical activity levels significantly after 12 weeks, demonstrating the program's effectiveness in promoting a more active lifestyle compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 12-week home-based exercise program on quality of life, psychological health, and the level of physical activity in colorectal cancer survivors: a randomized controlled trial. Kim, JY., Lee, MK., Lee, DH., et al.[2019]

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]

High-intensity exercise (HIE) significantly improved cardiorespiratory fitness (V̇O2peak) and body composition in colorectal cancer survivors over 4 weeks, showing increases in both absolute and relative V̇O2peak, while moderate-intensity exercise (MIE) did not yield similar benefits.

HIE led to increases in lean mass and decreases in fat mass and fat percentage, demonstrating its efficacy and safety as an intervention for improving health outcomes in colorectal cancer survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of high-intensity compared with moderate-intensity exercise training on cardiorespiratory fitness and body composition in colorectal cancer survivors: a randomised controlled trial. Devin, JL., Sax, AT., Hughes, GI., et al.[2022]

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]

A pilot study involving 30 colorectal cancer patients showed that exercise training after adjuvant chemotherapy is feasible and safe, with patients achieving significant improvements in physical performance, weight loss, and body fat reduction over one year.

Despite the positive outcomes, compliance was a major issue, with 33.3% of participants dropping out due to non-compliance, highlighting the need for strategies to enhance adherence in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients. Piringer, G., Fridrik, M., Fridrik, A., et al.[2019]

A 12-week supervised exercise program for colorectal cancer survivors was found to be feasible, with a high adherence rate of 91% and a completion rate of over 93% for assessments, indicating strong participant engagement.

The program significantly improved health-related physical fitness, including increases in peak oxygen uptake and body strength, as well as reductions in waist circumference and body fat, which may enhance quality of life and survival for CRC survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a 12-week supervised exercise intervention for colorectal cancer survivors. Sellar, CM., Bell, GJ., Haennel, RG., et al.[2022]

Physical activity (PA) interventions significantly improved disease-specific quality of life, PA levels, and maximum oxygen uptake in colorectal cancer (CRC) survivors, based on a systematic review of 7 randomized controlled trials involving 803 participants.

Despite these benefits, the PA interventions did not lead to significant improvements in fatigue or body mass index, highlighting the need for further research to optimize PA delivery methods for CRC survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Interventions for Colorectal Cancer Survivors: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Jung, Y., Chung, J., Son, H.[2021]

In a study of 321 colorectal cancer survivors, 57% were able to meet the recommended exercise guideline of over 150 minutes per week, highlighting the potential for regular physical activity in this population.

Key factors influencing exercise levels included personal beliefs about exercise, functional status, and environmental barriers like time constraints and weather, suggesting that tailored support from healthcare providers could enhance exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Influencing Amount of Weekly Exercise Time in Colorectal Cancer Survivors. Chou, YJ., Lai, YH., Lin, BR., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cardiorespiratory Fitness and Body Composition Responses to Different Intensities and Frequencies of Exercise Training in Colorectal Cancer Survivors. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A longitudinal study of exercise barriers in colorectal cancer survivors participating in a randomized controlled trial. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Effects of a 12-week home-based exercise program on quality of life, psychological health, and the level of physical activity in colorectal cancer survivors: a randomized controlled trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Colorectal cancer survivorship: movement matters. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The influence of high-intensity compared with moderate-intensity exercise training on cardiorespiratory fitness and body composition in colorectal cancer survivors: a randomised controlled trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Development process of an evidence-based exercise program for post-operative colorectal cancer patients. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of a 12-week supervised exercise intervention for colorectal cancer survivors. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Physical Activity Interventions for Colorectal Cancer Survivors: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Factors Influencing Amount of Weekly Exercise Time in Colorectal Cancer Survivors. [2018]