Personalized prehabilitation program for cancer surgery patients

Multimodal Prehabilitation in Cancer Surgery PROPOSE Trial (PRehabilitation in Oncological Patients undergOing SurgEry): A Randomized Trial

This study tests a personalized program that combines exercise, nutrition, and anxiety relief to see if it helps high-risk cancer surgery patients recover better and avoid complications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Università Vita-Salute San Raffaele (other)
• Locations: 9 sites (Catanzaro, Italy and 8 other locations)
• Trial ID: NCT06788834 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a personalized, multidisciplinary pre-operative prehabilitation program designed to reduce complications and enhance recovery in high-risk cancer surgery patients. The program includes exercise training, nutritional therapy, and anxiety reduction techniques, aiming to improve patients' functional capacity before undergoing major abdominal, thoracic, or gynecological surgeries. A total of 400 patients will be randomly assigned to either the prehabilitation intervention group or a control group receiving standard care. The study seeks to address the physiological stress and functional decline associated with cancer surgery.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 scheduled for elective major abdominal, thoracic, or gynecological cancer surgery.

Not a fit: Patients with severe comorbid conditions or optimal functional and nutritional status may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve recovery outcomes and reduce complications for patients undergoing cancer surgery.

How similar studies have performed: While the concept of prehabilitation is gaining attention, quantifiable evidence of its effectiveness remains underexplored, making this approach somewhat novel.

Eligibility criteria

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).

Where this trial is running

Catanzaro, Italy and 8 other locations

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

Study contacts

• Principal investigator: Marina Pieri, Medical Doctor — IRCCS Ospedale San Raffaele
• Study coordinator: Marina LG Pieri, Medical Doctor

Conditions: Cancer Surgery, Prehabilitation, Functional recovery, Relaxation, Exercise, Diet, Nutrition, Functional walking