Prehabilitation for Colorectal Cancer

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

Trial Summary

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 data supports the effectiveness of the treatment Prehabilitation for Colorectal Cancer?

Research shows that prehabilitation, which includes exercise, nutrition, and psychological support before surgery, can improve physical fitness and reduce complications after surgery for colorectal cancer patients. Studies found that patients who underwent prehabilitation had better physical condition and fewer postoperative complications compared to those who did not. ^{1 2 3 4 5}

Is prehabilitation safe for humans?

Prehabilitation, which includes exercise and nutritional programs before surgery, has been shown to be safe for humans, with studies reporting no adverse events and high compliance rates among participants. ^{2 3 5 6 7}

How is prehabilitation treatment different for colorectal cancer?

Prehabilitation for colorectal cancer is unique because it focuses on improving a patient's physical condition before surgery through a combination of exercises, nutrition, and psychological support, which can help enhance recovery after surgery. Unlike standard treatments that focus on the surgery itself, prehabilitation aims to optimize the patient's health beforehand, especially benefiting older or frail patients who are at higher risk for complications. ^{1 2 4 8 9}

What is the purpose of this trial?

Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions), 60% of older elective colorectal cancer surgery patients with poor physical function were unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic cut-point. Compared to the patients that attained \>400m 6MWD preoperatively, twice as many of \<400m patients were malnourished. Malnutrition has long been associated with worse functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally deficient patients, the etiology for their poor physical function is malnutrition. Correction of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and improve patient outcomes.

Research Team

Chelsia Gillis, RD PhD

Principal Investigator

McGill University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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 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]

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 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]

References

1. England 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. [2021]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Multimodal prehabilitation service for patients with colorectal cancer: the challenges of implementation. [2023]

4. England 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. [2023]

5. Germany 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Efficiency of the BEFORE (Better Exercise and Food, Better Recovery) Prehabilitation Program. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

"I am busy surviving" - Views about physical exercise in older adults scheduled for colorectal cancer surgery. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Prehabilitation for patients with colorectal cancer: a snapshot of current daily practice in Dutch hospitals. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The effects of physical prehabilitation in elderly patients undergoing colorectal surgery: a systematic review. [2022]