Trimodal Prehabilitation for Colorectal Cancer

(PrehabCRC Trial)

Overseen By Jordan Leitch, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jordan Leitch

Disqualifiers: Refusal, Language barrier, 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: 2

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical pilot is to determine the feasibility of implementing trimodal prehabilitation within the current perioperative infrastructure in patients having major colorectal surgery for resection of a cancer (CRC). Trimodal prehabilitation includes exercise, nutrition and mindfulness coaching and support which has been shown to improve physical status, mental preparation and to reduce loss of lean body mass in CRC patients. The primary questions this study aims to answer are: Is delivery of trimodal prehabilitation feasible within our current perioperative infrastructure and does prehabilitation impact outcomes in these patients? Researchers will compare this newly recruited prehabilitation cohort to a historical cohort of patients who did not receive prehabilitation in terms of mortality, length of stay, complications, readmissions, emergency department visits and non-home discharge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that trimodal prehabilitation, which includes exercise, nutritional support, and anxiety reduction, can improve recovery after colorectal cancer surgery by enhancing physical and psychological resilience. Patients who underwent this treatment had better functional outcomes and fewer postoperative complications compared to those who did not. ^{1 2 3 4 5}

Is trimodal prehabilitation safe for humans?

The studies on trimodal prehabilitation for colorectal cancer patients show that it is generally safe, with no adverse events reported during the programs. ^{1 3 6 7 8}

How is the trimodal prehabilitation treatment for colorectal cancer different from other treatments?

Trimodal prehabilitation is unique because it combines exercise, nutritional counseling with protein supplements, and anxiety reduction techniques to prepare patients for surgery, aiming to improve recovery and functional capacity, unlike standard care which may not include these comprehensive pre-surgery interventions. ^{1 3 4 6 9}

Research Team

Jordan Leitch

Principal Investigator

Queen's University

Eligibility Criteria

This trial is for adults aged 18 or older who are scheduled to undergo major surgery for colorectal cancer, such as colectomy, low anterior resection, or abdominoperineal resection. It's not specified who can't join the trial.

Inclusion Criteria

I have had major surgery for colorectal cancer.

Exclusion Criteria

I cannot understand or complete questionnaires in English.

I do not want to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Prehabilitation

Participants engage in a trimodal prehabilitation program including exercise, nutrition, and mindfulness coaching prior to surgery

4-6 weeks

Twice-weekly progress checks for some participants

Surgery

Participants undergo major colorectal surgery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of complications and discharge outcomes

4 weeks

Regular follow-up assessments

Treatment Details

Interventions

• Trimodal Prehabilitation

Trial Overview The study tests a 'trimodal prehabilitation' approach combining exercise, nutrition, and mindfulness coaching before major colorectal surgery. The aim is to see if this method is doable within current care systems and if it improves patient outcomes compared to past patients who didn't get this support.

Participant Groups

Group I: Progress Check Experimental Treatment 3 Interventions

This arm will include pre- and post-prehabilitation questionnaires as well as twice weekly progress checks by the research assistant to check on participant progress, answer questions and provide accountability and motivation.

Group II: No Progress Check Experimental Treatment 3 Interventions

This arm will include only pre- and post-prehabilitation questionnaires.

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

Approved in European Union as Trimodal Prehabilitation for:

• Preparation for colorectal cancer surgery

Approved in United States as Trimodal Prehabilitation for:

• Preparation for colorectal cancer surgery

Approved in Canada as Trimodal Prehabilitation for:

• Preparation for colorectal cancer surgery

Who Is Running the Clinical Trial?

Jordan Leitch

Lead Sponsor

Trials

1

Recruited

50+

Jordan Leitch

Lead Sponsor

Trials

2

Recruited

520+

Findings from Research

A trimodal prehabilitation program that includes exercise, nutritional counseling, and anxiety reduction significantly improved postoperative functional walking capacity in colorectal cancer patients, with a notable increase of 84.5 meters at 8 weeks post-surgery compared to the control group.

Patients who participated in the prehabilitation program had a higher recovery rate, with 81% fully recovered at 8 weeks, compared to only 40% in the control group, indicating that this comprehensive approach may enhance recovery outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Li, C., Carli, F., Lee, L., et al.[2022]

Trimodal prehabilitation did not significantly reduce postoperative mortality or complications in older surgical patients, based on a meta-analysis of 10 studies involving 1553 participants.

However, it did lead to a notable improvement in functional status, as measured by the 6-minute walk test at 4 weeks post-surgery, indicating potential benefits in recovery despite no impact on mortality or complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trimodal prehabilitation for older surgical patients: a systematic review and meta-analysis. Liu, C., Lu, Z., Zhu, M., et al.[2022]

In a study of 878 patients with gastrointestinal tumors, trimodal pre-rehabilitation significantly improved preoperative nutritional status, sleep quality, psychological state, and physical function compared to routine preoperative care.

Patients who underwent trimodal pre-rehabilitation experienced shorter hospital stays, lower hospitalization costs, and a better quality of life three months post-discharge, indicating its effectiveness in enhancing recovery during the perioperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of trimodal pre-rehabilitation on the rehabilitation of patients with gastrointestinal tumors in the perioperative period. Li, Q., Wang, Y., Jin, T., et al.[2022]

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]

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]

The trimodal prehabilitation protocol significantly reduced the overall postoperative morbidity in colorectal cancer patients, as indicated by a decrease in the Comprehensive Complication Index from 13.2 to 11.5.

Patients who underwent the prehabilitation protocol experienced a shorter overall hospital stay, decreasing from 6 days to 4 days, highlighting its potential benefits in recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-center prospective observational study on the effect of trimodal prehabilitation in colorectal surgery. Mora López, L., Pallisera Llovera, A., Serra-Aracil, X., et al.[2021]

In a study involving 185 participants, those who underwent multimodal prehabilitation (exercise, nutrition, and anxiety coping techniques) showed significant improvements in walking capacity before and after colorectal surgery compared to those who only received rehabilitation after surgery.

The prehabilitation group had a higher percentage of patients (60%) experiencing significant improvements in physical fitness, demonstrating that preoperative conditioning can enhance functional capacity and recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal prehabilitation improves functional capacity before and after colorectal surgery for cancer: a five-year research experience. Minnella, EM., Bousquet-Dion, G., Awasthi, R., et al.[2017]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Trimodal prehabilitation for older surgical patients: a systematic review and meta-analysis. [2022]

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

Effect of trimodal pre-rehabilitation on the rehabilitation of patients with gastrointestinal tumors in the perioperative period. [2022]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

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

6. 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]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. Spain pubmed.ncbi.nlm.nih.gov

A single-center prospective observational study on the effect of trimodal prehabilitation in colorectal surgery. [2021]

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

Multimodal prehabilitation improves functional capacity before and after colorectal surgery for cancer: a five-year research experience. [2017]