Prehabilitation program for cancer patients undergoing major gastrointestinal surgery
Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway.
This study is testing whether a personalized program that includes exercise, nutrition, and stress relief can help cancer patients recover better and have fewer complications after major stomach surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 2 sites (Cagliari, Sardegna and 1 other locations) |
| Trial ID | NCT06404489 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a personalized, multidisciplinary prehabilitation program aimed at reducing severe postoperative complications in patients undergoing major oncological gastrointestinal surgery. It is a randomized controlled trial involving 400 patients who will be divided into two groups: one receiving a multimodal prehabilitation program that includes exercise training, nutritional therapy, and anxiety-reducing techniques, and the other receiving standard care. The primary goal is to assess the impact of prehabilitation on postoperative complications within 30 days, while secondary outcomes include recovery time, hospital stay length, and quality of life metrics.
Who should consider this trial
Good fit: Ideal candidates are adult patients over 18 scheduled for elective gastrointestinal surgery due to cancer.
Not a fit: Patients with severe comorbid conditions or those unable to complete study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce postoperative complications and improve recovery for cancer patients undergoing major surgery.
How similar studies have performed: Other studies have shown promising results with prehabilitation approaches in surgical patients, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult patients (age \> 18 years) scheduled for elective gastrointestinal surgery for cancer. * Signed informed consent Exclusion Criteria: 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. * Pregnancy
Where this trial is running
Cagliari, Sardegna and 1 other locations
- Azienda Ospedaliera Universitaria — Cagliari, Sardegna, Italy (Not_yet_recruiting)
- IRCCS San Raffaele Scientific Institute — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Luigi Beretta, Prof
- Email: beretta.luigi@hsr.it
- Phone: +39022643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.