Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS) (PROGRESS)

May 5, 2026 updated by: Giovanni Landoni, Università Vita-Salute San Raffaele

Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway.

The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period constitutes a unique opportunity to address comorbidities and modifiable risk factors, improve functional capacity and address deficiencies in physiologic reserve, which might otherwise preclude surgery or significantly impede recovery.

Therefore, the aim of this study is to evaluate the efficacy of a multimodal program of prehabilitation in patients undergoing major oncological gastrointestinal surgery. The hypothesis is that severe post-operative complications within 30 days will be reduced in the treatment group compared to the control group.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a 2-arm randomized multicentric controlled trial to test the efficacy of a personalized, multidisciplinary, preoperative conditioning program to reduce severe complications and facilitate recovery in patients undergoing major oncological gastrointestinal surgery.

400 patients will be randomized (ratio 1:1) and allocated either to the intervention group (Prehabilitation), or to the control group (which will be treated according to usual standard of care within Enhanced Recovery After Surgery (ERAS) pathways).

Multimodal prehabilitation is a preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline.

The primary objective is to evaluate the effect of a multimodal program of prehabilitation on postoperative severe complications.

Secondary outcomes include time to functional recovery, length of hospital stay, complication severity, proportion of patients returning to preoperative functional walking capacity and self-reported activity status and generic health related quality of life at 30 days after surgery.

Included patients will be randomized and allocated either to the intervention group, which will receive 4 weeks of prehabilitation, or to the control group, which will receive no prehabilitation. All patients will be reassessed the day before surgery, 30 days and 3 months after surgery.

Patients enrolled in treatment group will not receive any additional medication but only a multimodal program to optimize their preoperative functional capacity.

Within 30 days prior to scheduled surgery, participants of both groups will undergo a specialized multidisciplinary assessment with a physician, a certified physiotherapist, registered dietitian and psychology trained personnel. All tests will be performed following international guidelines and standardized verbal instructions. A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect.

Statistical analysis will be performed according to study sites, type of surgery (esophageal, gastric, colonic, rectal) and neoadjuvant treatment.

Study Type

Interventional

Enrollment (Estimated)

400

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
      • Milan, Italy, 20132
        • IRCCS San Raffaele Scientific Institute
    • Sardinia
      • Cagliari, Sardinia, Italy
        • Azienda Ospedaliera Universitaria

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:

  • All adult patients (age > 18 years) scheduled for elective gastrointestinal surgery for cancer.
  • Signed informed consent

Exclusion Criteria:

Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as:

  • acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis)
  • severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 <50% pred, end-stage kidney or liver disease);
  • American Society of Anesthesiologists (ASA) physical status classes 4-5.
  • disabling orthopedic and neuromuscular disease.
  • psychosis, dementia;
  • symptomatic anemia.
  • Pregnancy

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Standard care treatment. Application of ERAS pathways (Enhanced Recovery After Surgery)
Experimental: Prehabilitation
Prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline.
Behavioral: Multimodal prehabilitation Program

A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect.

The duration of program will be set at 4 weeks. All activities will be performed in dedicated suites at each site, under supervision of qualified health professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: Evaluation of severe post-operative complications within 30 days
Reduction of incidence of postoperative complications.
Evaluation of severe post-operative complications within 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lenght of hospital stay
Time Frame: 30 days after surgery
Reduction of lenght of hospital stay in treatment group
30 days after surgery
Proportion of patients returning to preoperative functional walking capacity
Time Frame: 30 days after surgery, 90 days follow up after surgery
Improving return to basal functional preoperative capacity
30 days after surgery, 90 days follow up after surgery

Collaborators and Investigators

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

Sponsor

Università Vita-Salute San Raffaele

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)

May 16, 2024

Primary Completion (Actual)

April 19, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROGRESS - CET 191-2023

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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