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Multimodal Prehabilitation in Cancer Surgery

RecruitingNAAges 18 Years - anyAllUniversità Vita-Salute San Raffaele
NCT06788834 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patient (age \> 18 years); * Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery; * Signed informed consent. Exclusion Criteria: A) Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as: * Acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis); * Severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 \<50% pred, end-stage kidney or liver disease); * American Society of Anesthesiologists (ASA) physical status classes 4-5; * Disabling orthopedic and neuromuscular disease; * Psychosis, dementia; * Symptomatic anemia with a hemoglobin value \< 7 gr/dl. B) Patients with both optimal functional capacity (a Duke activity status index \[DASI\] score \> 45) and optimal nutritional status (NRS-nutrition screening tool-score \< 2).
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What it tests

  • Multimodal prehabilitation Program
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Where

9 sites
Policlinico Universitario AOU Renato Dulbecco di Catanzaro
Catanzaro, Italy
AOU Careggi
Florence, Italy
Ospedale Galliera di Genova
Genova, Italy
ASSTN GOM Niguarda
Milan, Italy
IRCCS Ospedale San Gerardo dei Tintori
Monza, Italy
Ospedale Vanvitelli di Napoli
Naples, Italy
AOPD Padova
Padova, Italy
Azienda sanitaria universitaria Friuli Centrale (ASU FC)
Udine, Italy

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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