Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)

Trial Title: Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)

NCT ID: NCT06404489

Condition: Oncological Patients
Major Surgery

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

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Multimodal prehabilitation Program
Description: 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.
Arm group label: Prehabilitation

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.

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Azienda Ospedaliera Universitaria

Address:
City: Cagliari
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Gabriele Finco, MD

Facility:
Name: IRCCS San Raffaele Scientific Institute

Address:
City: Milan
Zip: 20132
Country: Italy

Status: Recruiting

Contact:
Last name: Giovanni Landoni, Prof
Email: landoni.giovanni@hsr.it

Investigator:
Last name: Luigi Beretta, Prof
Email: Principal Investigator

Investigator:
Last name: Stefano Turi, MD
Email: Sub-Investigator

Start date: May 16, 2024

Completion date: October 2025

Lead sponsor:
Agency: Università Vita-Salute San Raffaele
Agency class: Other

Source: Università Vita-Salute San Raffaele

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06404489