Actively Recruiting
Multimodal Prehabilitation in Cancer Surgery
Led by Università Vita-Salute San Raffaele · Updated on 2025-08-07
400
Participants Needed
9
Research Sites
82 weeks
Total Duration
On this page
Sponsors
U
Università Vita-Salute San Raffaele
Lead Sponsor
P
Prof. Pasquale Sansone
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Multimodal Prehabilitation in Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (age > 18 years)
- Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery
- Signed informed consent
You will not qualify if you...
- Acute or unstable cardio-respiratory conditions such as unstable angina or symptomatic severe aortic stenosis
- Severe or end-stage organ diseases including cardiac failure NYHA classes III-IV, COPD with FEV1 <50% predicted, end-stage kidney or liver disease
- American Society of Anesthesiologists (ASA) physical status classes 4-5
- Disabling orthopedic and neuromuscular diseases
- Psychosis or dementia
- Symptomatic anemia with hemoglobin value less than 7 g/dl
- Patients with both optimal functional capacity (Duke activity status index score > 45) and optimal nutritional status (NRS-nutrition screening tool score < 2)
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Policlinico Universitario AOU Renato Dulbecco di Catanzaro
Catanzaro, Italy, Italy, 88100
Actively Recruiting
2
AOU Careggi
Florence, Italy, Italy, 50134
Not Yet Recruiting
3
Ospedale Galliera di Genova
Genova, Italy, Italy, 16128
Not Yet Recruiting
4
ASSTN GOM Niguarda
Milan, Italy, Italy, 20162
Not Yet Recruiting
5
IRCCS Ospedale San Gerardo dei Tintori
Monza, Italy, Italy, 20900
Not Yet Recruiting
6
Ospedale Vanvitelli di Napoli
Naples, Italy, Italy, 80129
Actively Recruiting
7
AOPD Padova
Padova, Italy, Italy, 35128
Not Yet Recruiting
8
Azienda sanitaria universitaria Friuli Centrale (ASU FC)
Udine, Italy, Italy, 33100
Not Yet Recruiting
9
IRCCS Ospedale San Raffaele
Milan, Milan, Italy, 20132
Actively Recruiting
Research Team
M
Marina LG Pieri, Medical Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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