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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a program combining exercise, nutrition, and mindfulness before surgery can benefit patients with colorectal cancer undergoing major surgery. Researchers aim to determine if this plan, called trimodal prehabilitation (a type of preoperative rehabilitation), can be easily integrated into current surgery preparations and improve recovery outcomes. Participants will complete questionnaires and have their progress monitored by a research assistant. The trial seeks individuals scheduled for major colorectal surgery, such as a colectomy, who can communicate in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that could enhance recovery for future patients.

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 prior data suggests that trimodal prehabilitation is safe for colorectal cancer patients?

Research has shown that trimodal prehabilitation is generally safe for people with colorectal cancer. This method combines exercise, nutrition, and mindfulness coaching to prepare patients for surgery.

Studies have found that this program helps reduce muscle loss after surgery, which is important for recovery. While some reports mention complications after surgery, these are common in colorectal surgeries and not directly linked to the prehabilitation program.

Overall, the treatment is well-tolerated, with no specific reports of serious side effects from the prehabilitation program. Therefore, it appears to be a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about trimodal prehabilitation for colorectal cancer because it takes a comprehensive approach to prepare patients both physically and mentally before surgery. Unlike current treatments that mainly focus on post-surgical recovery, this method emphasizes fitness, nutrition, and mental health beforehand, potentially leading to better surgical outcomes. By integrating regular progress checks with a research assistant for some participants, it adds a layer of motivation and accountability that could enhance the overall effectiveness of the prehabilitation process.

What evidence suggests that trimodal prehabilitation is effective for colorectal cancer?

Research shows that trimodal prehabilitation, which includes exercise, nutrition, and mindfulness, can greatly benefit patients undergoing colorectal cancer surgery. Studies have found that these programs reduce serious post-surgery complications and prepare patients physically and mentally. One study found that patients following this program had better outcomes and lost less muscle mass. Another study showed that this approach shortened hospital stays and improved overall recovery. In this trial, participants will be divided into two groups: one will receive progress checks and support, while the other will not. These findings suggest that trimodal prehabilitation could be an important part of the care plan for patients undergoing colorectal cancer surgery. ^{3 4 6 7 8}

Who Is on the Research Team?

Jordan Leitch

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

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 do not want to participate in the study.

I cannot understand or complete questionnaires in English.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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 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]

Citations

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

The Effects of Multimodal Prehabilitation on Postoperative ... Eligible trials compared multimodal prehabilitation with standard care in elective colorectal resections. The primary outcome was overall ...

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

Multimodal Prehabilitation for Colorectal Cancer Patients The aim of this study is to analyse clinical outcomes of prehabilitation when implemented as standard of care according to the proposed uniform protocols.

3. 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 ...

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

Multimodal prehabilitation in colorectal Perioperative care will be based on a standardized, multi-element, evidence-based, comprehensive, ERAS guideline in line with the consensus review of optimal.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798324003226

Multimodal prehabilitation in elective oncological colorectal ... The PREHAB trial revealed that prehabilitation in colorectal surgery leads to a reduction of severe complications and enhanced functional capacity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614948/

A randomized controlled clinical trial on multimodal ... The primary aim of this study was to analyse the effects of a multimodal prehabilitation program in colorectal cancer patients to improve functional capacity.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0261561418312019

Trimodal prehabilitation for colorectal surgery attenuates ... Trimodal prehabilitation attenuated the post-surgical LBM loss compared to the loss observed in patients who received the rehabilitation intervention.

8. cinj.org cinj.org/sites/cinj/files/documents/Impact%20of%20a%20Trimodal%20Prehabilitation%20Program%20on%20Functional%20Recovery%20After%20Colorectal%20Cancer%20Surgery%20A%20Pilot%20Study.pdf

Impact of a Trimodal Prehabilitation Program on Functional ... First, adherence to the intense stationary- bicycle-based exercise program was low, and the results were poor. Colorectal cancer patients can ...