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Multimodal Prehabilitation in Cancer Surgery

Study acronym: PROPOSE-RCT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 7, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Site details revised at 1 of 9 sitesv5
  2. Site details revised at 2 of 9 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 8 to 9
    • Start date changed from estimate of Feb 2025 to Jan 30, 2025
    v3
  4. Secondary endpoints: details revised at 2 of 6 entries
    • Site details revised at 8 of 8 sites
    • Study description expanded, about 5 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Cancer Surgery
Related terms Motor Activity
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov