Multimodal Prehabilitation in Cancer Surgery
ConditionCancer Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità Vita-Salute San Raffaele
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult patient (age > 18 years);
Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;
Signed informed consent.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Multimodal prehabilitation Program
BehavioralA 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: PrehabilitationExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Assess the impact of prehabilitation on severe postoperative complications among high-risk patients undergoing oncological surgery
The proportion of patients experiencing severe postoperative complications within 30 days after surgery defined as grade 3a or greater according to the Clavien-Dindo classification
Time frame
30 days after surgerySecondary outcomes
1
Time to Functional Recovery (TFR)
Faster return to basal functional preoperative capacity in treatment group
Time frame
30 days after surgery2
Lenght of hospital stay (LOS)
Reduction of lenght of hospital stay in treatment group
Time frame
30 days after surgery3
Days at home up to 30 days after surgery (DAH-30)
The mean number of days at home in the first 30 days after surgery will be compared between groups
Time frame
30 days after surgery4
Complication severity
Assess complication severity as measured by the Comprehensive Complication Index (CCI)
Time frame
30 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Università Vita-Salute San Raffaele
Lead sponsor
Prof. Pasquale Sansone
Collaborator
Prof. Eugenio Garofalo
Collaborator
Prof. Tiziana Bove
Collaborator
Dr. Claudia Brusasco
Collaborator
Prof. Gabriele Baldini
Collaborator
Dr. Nicola Passuello
Collaborator
Dr. Monica Gualtierotti
Collaborator
Prof. Luca Carlo Nespoli
Collaborator
Source ClinicalTrials.gov