Prehabilitation for Colorectal Cancer

Recruiting at 1 trial location

Overseen By Natalia Tomborelli Bellafronte, RD PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Dementia, Parkinson's, Stroke, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults scheduled for colorectal cancer surgery improve physical function by addressing malnutrition through prehabilitation. Researchers believe that correcting nutritional deficiencies may enhance patients' physical fitness before surgery, potentially leading to better outcomes. Participants will receive personalized nutrition plans, and some will also follow tailored exercise routines. The trial seeks patients aged 65 and older who have planned colorectal cancer surgery, struggle with walking 400 meters, and experience malnutrition. As an unphased trial, this study offers a unique opportunity for patients to potentially enhance surgical outcomes through personalized care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation protocol is safe for colorectal cancer patients?

Research shows that prehabilitation, which involves improving nutrition and exercise, is generally safe for patients undergoing colorectal cancer surgery. Studies have found that this approach can prepare the body for surgery, leading to fewer complications afterward. One study found that patients who participated in prehabilitation experienced fewer serious medical issues post-surgery.

Observational studies also suggest that prehabilitation might reduce the risk of postoperative problems. Enhancing a patient's nutrition and physical fitness before surgery can make them stronger and better able to recover quickly.

Most reports do not mention significant negative effects from prehabilitation. Instead, they highlight benefits like shorter hospital stays. Overall, this approach seems well-tolerated, focusing on better nutrition and exercise to strengthen patient health before surgery. ^{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 prehabilitation in colorectal cancer patients, focusing on personalized nutrition and exercise plans. Unlike standard treatments that primarily target the cancer directly, this approach aims to improve patients' overall health and strength before surgery, potentially leading to better recovery outcomes. By tailoring nutrition and exercise to individual needs, the trial seeks to enhance patients' resilience, making them better equipped to handle surgery and treatment. This innovative strategy could transform how we prepare patients for cancer treatment, emphasizing wellness and recovery from the outset.

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

This trial will compare two approaches to prehabilitation for colorectal cancer surgery. Research has shown that combining good nutrition and exercise before surgery can improve recovery and reduce complications. Participants in the "Nutrition and exercise" arm will receive a personalized program that includes both nutrition and exercise interventions. Studies have found that such programs help patients walk longer distances in six minutes, indicating better surgical outcomes. Those who follow these programs often experience fewer issues after surgery and spend less time in the hospital.

Participants in the "Nutrition only" arm will focus solely on improving their diet. Enhancing diet can greatly benefit undernourished individuals, potentially boosting their physical abilities. Addressing malnutrition alone might help patients walk further, which is linked to better recovery. ^{2 3 4 6 7}

Who Is on the Research Team?

Chelsia Gillis, RD PhD

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for older adults (65+) with colorectal cancer who are malnourished and have a low walking distance (less than 400m in six minutes). They must be scheduled for surgery but not have metastatic cancer or conditions like dementia, Parkinson's, or stroke that would make exercise unsafe.

Inclusion Criteria

I am 65 years old or older.

I am scheduled for surgery to remove part of my colon due to cancer.

I can walk less than 400 meters in 6 minutes.

Exclusion Criteria

I do not have dementia, Parkinson's, or paralysis from a stroke that stops me from exercising.

My cancer has spread to other parts of my body.

I cannot communicate in English or French, nor can I bring someone who does.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants receive nutrition prehabilitation alone or with supportive exercise to improve physical function before surgery

4 weeks

Weekly in-person or virtual visits

Follow-up

Participants are monitored for safety and effectiveness after prehabilitation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation

Trial Overview The study tests if improving nutrition alone can help patients walk farther before surgery. It focuses on those unable to meet the pre-surgery walking goal despite usual prehabilitation, which includes nutrition, exercise, and mental support.

How Is the Trial Designed?

Group I: Nutrition only Experimental Treatment 1 Intervention

The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.

Group II: Nutrition and exercise Experimental Treatment 2 Interventions

The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets. The exercise intervention will be personalized based on a comprehensive assessment to include both a resistance and an aerobic component in the form of a "snack".

Prehabilitation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in United States as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Approved in Canada as Prehabilitation for:

• Preparation for liver transplantation in patients with cirrhosis

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Published Research Related to This Trial

In the Netherlands, nearly all hospitals performing colorectal cancer surgery routinely screen patients for frailty, nutritional status, and anemia, indicating a strong commitment to preoperative assessment.

While 67% of hospitals provide some form of prehabilitation, there is significant variability in the design and content of these programs, highlighting the need for standardized guidelines to improve patient recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation for patients with colorectal cancer: a snapshot of current daily practice in Dutch hospitals. Molenaar, CJL., Reudink, M., Sabajo, CR., et al.[2023]

A 4-week multimodal prehabilitation program for colorectal cancer patients over 64 years old was found to be feasible, with 91.7% compliance in exercise training and 66.7% compliance in nutritional intervention.

No adverse events were reported during the program, indicating that it is a safe approach to potentially reduce postoperative complications in elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Efficiency of the BEFORE (Better Exercise and Food, Better Recovery) Prehabilitation Program. Tweed, TTT., Sier, MAT., Van Bodegraven, AA., et al.[2021]

A feasibility study involving 8 frail patients with colorectal cancer showed that a multimodal prehabilitation program, including high-intensity interval training and nutritional support, can be successfully implemented before surgery, with 87% adherence to training sessions.

Despite challenges in measuring compliance with high-intensity training, the study indicates that this approach is manageable for elderly patients, suggesting potential benefits for improving surgical outcomes in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit for Surgery-feasibility of short-course multimodal individualized prehabilitation in high-risk frail colon cancer patients prior to surgery. Bojesen, RD., Jørgensen, LB., Grube, C., et al.[2022]

The Defining Standards in Colorectal Optimisation Study aims to create a consensus on key standards for reporting prehabilitation research in colorectal surgery, addressing the current variation in endpoints reported by different healthcare professionals.

The study will involve a systematic review and a Delphi process to ensure that both healthcare professionals and patients contribute to defining important standards, ultimately enhancing the quality and comparability of future prehabilitation studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining standards in colorectal optimisation: a Delphi study protocol to achieve international consensus on key standards for colorectal surgery prehabilitation. Pearson, I., Blackwell, S., Fish, R., et al.[2021]

A review of five studies involving 353 older patients (average age over 60) undergoing colorectal surgery found that while physical prehabilitation improved some physical measures like walking distance and respiratory endurance, it did not significantly reduce postoperative complications or hospital stay length.

The studies reviewed had moderate quality and varied compliance rates for prehabilitation programs, highlighting the need for better-defined patient groups and standardized outcomes to enhance the effectiveness of prehabilitation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of physical prehabilitation in elderly patients undergoing colorectal surgery: a systematic review. Bruns, ER., van den Heuvel, B., Buskens, CJ., et al.[2022]

Home-based prehabilitation for colorectal cancer patients significantly reduced postoperative complications and hospital stay compared to standard care, with a complication rate of 17.4% in the prehabilitation group versus 33.3% in the standard care group.

Patients who underwent prehabilitation showed a notable improvement in physical condition, as evidenced by a significant increase in the 6-minute walk test distance (+68.9 m) six weeks after surgery, indicating enhanced recovery and functional capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based prehabilitation improves physical conditions measured by ergospirometry and 6MWT in colorectal cancer patients: a randomized controlled pilot study. Triguero-Cánovas, D., López-Rodríguez-Arias, F., Gómez-Martínez, M., et al.[2023]

A study involving 40 colorectal cancer patients showed that a 4-week multimodal prehabilitation program significantly improved postoperative recovery, with an average increase of 21.9 points in the Quality of Recovery-15 score compared to standard care.

This improvement was clinically relevant, exceeding the minimal difference of 8 points, indicating that prehabilitation can be an effective strategy for enhancing recovery in high-risk surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative multimodal prehabilitation before elective colorectal cancer surgery in patients with WHO performance status I or II: randomized clinical trial. Bojesen, RD., Dalton, SO., Skou, ST., et al.[2023]

A personalized multimodal prehabilitation program for 49 patients awaiting colorectal cancer surgery led to significant improvements in functional outcomes, such as increased physical activity and reduced fatigue, over a median duration of 24 days.

Patients who underwent prehabilitation experienced a lower rate of postoperative complications (50%) compared to a control group (67%), indicating that prehabilitation may enhance recovery and reduce risks associated with major surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal prehabilitation service for patients with colorectal cancer: the challenges of implementation. Boyle, H., Fullbrook, A., Wills, A., et al.[2023]

A qualitative study involving 15 older patients, 13 informal caregivers, and 9 healthcare providers identified key barriers to preoperative exercise for colorectal cancer surgery, including limited time, misunderstanding of information, and physical ailments.

Facilitators for engaging in preoperative exercise included clear communication from healthcare providers, low-cost programs, and the need for exercise to be tailored to individual preferences and easily accessible, highlighting the importance of personalized approaches in prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I am busy surviving" - Views about physical exercise in older adults scheduled for colorectal cancer surgery. Agasi-Idenburg, CS., Zuilen, MK., Westerman, MJ., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538375/

The Effects of Multimodal Prehabilitation on Postoperative ... Multimodal prehabilitation improves functional recovery and reduces overall complications in colorectal cancer surgery, though its effect on ...

2. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.19425

Prehabilitation Interventions in Patients Undergoing ... The results of this study indicate that implementing a multimodal prehabilitation program before colorectal cancer surgery effectively reduces ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0748798324007601

Review Article Real-life effectiveness of prehabilitation to ... Observational studies in a real-life setting showed that prehabilitation can reduce postoperative complications and LoS.

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1619959/full

Multimodal prehabilitation is an effective strategy to reduce ... Conclusion: The Mul prehabilitation program is the effective strategy for improving surgical outcomes in CRC patients. This comprehensive ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/counter/pdf/10.1186/s12885-018-5232-6.pdf?utm_source=consensus

Multimodal prehabilitation in colorectal The primary outcomes for measurement will be functional capacity (as assessed using the six-minute walk test (6MWT)) and postoperative status determined with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12338409/

Multimodal Prehabilitation for Colorectal Cancer Patients The aim of prehabilitation is to optimize patient specific modifiable risk factors before major surgery, in order to enhance the individual resilience.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36988937/

The PREHAB Randomized Clinical Trial This PREHAB trial demonstrates the benefit of a multimodal prehabilitation program before colorectal cancer surgery as reflected by fewer severe and medical ...