Multimodal Prehabilitation in Colorectal Cancer Patients

March 25, 2025 updated by: Carlo Feo, University Hospital of Ferrara

A Randomized Controlled Clinical Trial on Multimodal Prehabilitation in Colorectal Cancer Patients to Improve Functional Capacity and Lower Postoperative Complications.

Postoperative complications can occur in up to 50% of individuals undergoing colorectal resection and are associated with poor prognosis, increased costs, and lower health-related quality of life. Even in the absence of complications, after major surgery, patients reduce their physiological and functional capacity by 20-40% and show a higher level of fatigue for 6-8 weeks. Many of these negative effects can be decreased by applying specific ERAS (Enhanced Recovery After Surgery) programs which, by attenuating the neuro-endocrine response induced by surgical trauma, accelerate patients' post-operative convalescence and facilitate their return to functional activities.

In this study, the research group hypothesizes that a prehabilitation program based on physical exercise, nutritional optimization and psychological support (trimodal) carried out by patients in the 4 weeks before elective colorectal resection surgery can determine: 1) better physical performance 8 weeks after surgery (measured by the 6-minute walk test), 2) a possible decrease in postoperative complications, and 3) a reduction in in-hospital (direct) and post-hospital discharge (indirect) costs.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine the effect of prehabilitation on patients' functional capacity and postoperative complications. It is a randomized trial including 112 patients undergoing colorectal surgery for cancer. Patients will be allocated to intervention group receiving 4 weeks trimodal prehabilitation (N=56) or control group receiving no prehabilitation (N=56). After surgery, both groups will follow 8 weeks rehabilitation based on Enhanced Recovery After Surgery (ERAS) guidelines. The primary endpoint is functional capacity, secondary outcomes include postoperative complications and a cost-effectiveness analysis. Multimodal prehabilitation is expected to increase functional capacity and lower postoperative complications.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44123
        • Unità Operativa Qualità, Accreditamento, Ricerca organizzativa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients of age >18 years;
  • elective colorectal resection for colonic cancer.

Exclusion Criteria:

  • metastatic disease;
  • severe walking impairments;
  • renal failure stage >2;
  • ASA score >3;
  • preoperative chemo-radiation therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trimodal prehabilitation
physical exercise, psychological support and nutritional optimization 4-weeks before surgery
Other: Trimodal prehabilitation
Trimodal prehabilitation program (4-week physical exercise before surgery, nutritional optimization, and psychological support) in patients undergoing ERAS colorectal resection for cancer
No Intervention: control group without preoperative prehabilitation
Patients no receiveing prehabilitation and undergoing standard rehabilitation alone after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative functional capacity
Time Frame: From enrollment to the end of treatment at 8 weeks after surgery
The primary outcome for functional capacity was measured by the 6-Minute Walking Test (6MWT), chosen as a validated, objective measure of colorectal surgery recovery integrating all components of physical activity.
From enrollment to the end of treatment at 8 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: Within 30 days after surgery
To evaluate post-operative complications, the Clavien-Dindo classification has been used as a combined measure of morbidity and mortality.
Within 30 days after surgery
Hospital length of stay
Time Frame: Within 30 days after surgery
To evaluate the length of postoperative hospital stay
Within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Investigators

  • Principal Investigator: Carlo CF Feo, MD FACS, Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Estimated)

June 2, 2025

Study Completion (Estimated)

April 2, 2026

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 849/2019/Sper/AUSLFe
  • RF-2018- 12367272 (Other Grant/Funding Number: Italian Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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