Multimodal Prehabilitation in Cancer Surgery

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.

Conditions

• Cancer Surgery

Interventions

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

Sponsors & Collaborators

• Prof. Pasquale Sansone

  collaborator UNKNOWN

• Prof. Eugenio Garofalo

  collaborator UNKNOWN

• Prof. Tiziana Bove

  collaborator UNKNOWN

• Dr. Claudia Brusasco

  collaborator UNKNOWN

• Prof. Gabriele Baldini

  collaborator UNKNOWN

• Dr. Nicola Passuello

  collaborator UNKNOWN

• Dr. Monica Gualtierotti

  collaborator UNKNOWN

• Prof. Luca Carlo Nespoli

  collaborator UNKNOWN

• Università Vita-Salute San Raffaele

  lead OTHER

Principal Investigators

• Marina Pieri, Medical Doctor · IRCCS Ospedale San Raffaele

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-30

Primary Completion

2026-08-31

Completion

2026-09-30

Countries

• Italy

Study Locations