RecruitingNot ApplicableNCT06788834

Multimodal Prehabilitation in Cancer Surgery

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

Sponsor

Università Vita-Salute San Raffaele

Enrollment

400 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Cancer Surgery

Summary

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

Min Age: 18 Years

Inclusion Criteria3

Adult patient (age > 18 years);
Scheduled for elective major abdominal (including urological), thoracic (including breast) or gynecological cancer surgery;
Signed informed consent.

Exclusion Criteria8

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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Interventions

BEHAVIORALMultimodal prehabilitation Program

A 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.