RecruitingNot ApplicableNCT06788834

Multimodal Prehabilitation in Cancer Surgery

Multimodal Prehabilitation in Cancer Surgery PROPOSE Trial (PRehabilitation in Oncological Patients undergOing SurgEry): A Randomized Trial


Sponsor

Università Vita-Salute San Raffaele

Enrollment

400 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The PROPOSE RCT is a two-arm randomized controlled trial that will be conducted to test the efficacy of a personalized, multidisciplinary pre-operative prehabilitation program (preventive prehabilitation) to reduce serious complications and facilitate recovery after surgery in high-risk patients. The multimodal prehabilitation program is a preoperative intervention that includes exercise training, nutritional therapy and anxiety reduction techniques, with the aim of preventing or mitigating the functional decline brought about by surgery. 400 patients scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery will be enrolled. They will be randomized (1:1 ratio) and assigned either to the intervention group (Prehabilitation) or to the control group, which will only be treated according to the usual standard of care within the Enhanced Recovery After Surgery (ERAS) pathways.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Multimodal prehabilitation Program for people with cancer surgery. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMultimodal 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 effects. The duration of the program will be set at a minimum of three weeks.


Locations(9)

Policlinico Universitario AOU Renato Dulbecco di Catanzaro

Catanzaro, Italy, Italy

AOU Careggi

Florence, Italy, Italy

Ospedale Galliera di Genova

Genova, Italy, Italy

ASSTN GOM Niguarda

Milan, Italy, Italy

IRCCS Ospedale San Gerardo dei Tintori

Monza, Italy, Italy

Ospedale Vanvitelli di Napoli

Naples, Italy, Italy

AOPD Padova

Padova, Italy, Italy

Azienda sanitaria universitaria Friuli Centrale (ASU FC)

Udine, Italy, Italy

IRCCS Ospedale San Raffaele

Milan, Milan, Italy

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NCT06788834


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