Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)

NCT06404489 | Recruiting

• 1 other identifier: PROGRESS - CET 191-2023
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Oncological Patients; Major Surgery

Keywords

Prehabilitation; Multimodal prehabilitation program; Standard care treatment; Major gastrointestinal surgery; Hospital stay; Functional walking; Nutrition; Diet; Exercise; Relaxation; Oncology; Functional recovery; Anesthesiology

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Reduction of incidence of postoperative complications.

  Evaluation of severe post-operative complications within 30 days

Secondary Outcomes (2)

• Lenght of hospital stay

  30 days after surgery

• Proportion of patients returning to preoperative functional walking capacity

  30 days after surgery, 90 days follow up after surgery

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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

Control group

NO INTERVENTION

Standard care treatment. Application of ERAS pathways (Enhanced Recovery After Surgery)

Interventions

Multimodal prehabilitation Program BEHAVIORAL

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.

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (2)

Azienda Ospedaliera Universitaria

Cagliari, Sardinia, Italy

NOT YET RECRUITING

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Motor Activity; Neoplasms

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Luigi Beretta, Prof

CONTACT

+39022643; beretta.luigi@hsr.it

Turi Stefano, MD

CONTACT

+39022643; turi.stefano@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 8, 2024
• Study Start: May 16, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)