Multimodal Prehabilitation in Cancer Surgery

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.

NCT Number	NCT06788834
Lead Sponsor	Università Vita-Salute San Raffaele Collaborators: Prof. Pasquale Sansone, Prof. Eugenio Garofalo, Prof. Tiziana Bove, Dr. Claudia Brusasco, Prof. Gabriele Baldini, Dr. Nicola Passuello, Dr. Monica Gualtierotti, Prof. Luca Carlo Nespoli
Conditions	Cancer Surgery
Enrollment	400 participants
Start Date	2025-01-30
Primary Completion	2026-08 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2025-08-07