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Multimodal Prehabilitation in Cancer Surgery
Sponsor: Università Vita-Salute San Raffaele
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.
Official title: Multimodal Prehabilitation in Cancer Surgery PROPOSE Trial (PRehabilitation in Oncological Patients undergOing SurgEry): A Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-01-30
Completion Date
2026-09
Last Updated
2025-08-07
Healthy Volunteers
Yes
Conditions
Interventions
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 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