Improving recovery before pancreatic surgery
Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
This study tests whether a four-week program of exercise, nutrition support, and mental health help can improve recovery for people with pancreatic cancer before their surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 238 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT06069297 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of a four-week multimodal prehabilitation program on patients with localized pancreatic or periampullary cancer scheduled for curative surgery. The program includes physical exercise, nutritional support, and psychological interventions aimed at enhancing functional capacity and nutritional status. Patients will be randomized into either the intervention group receiving prehabilitation or a control group with no prehabilitation. The study also explores the impact of prehabilitation on biomarkers related to sarcopenia and cancer cachexia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with localized pancreatic or periampullary cancer who are scheduled for curative surgery.
Not a fit: Patients with metastatic disease, severe comorbidities, or those unable to participate in the prehabilitation regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve postoperative recovery and quality of life for patients undergoing pancreatic surgery.
How similar studies have performed: While multimodal prehabilitation has shown promise in gastrointestinal cancer surgery, high-quality evidence specifically for pancreatic cancer patients is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Indication for curative resection for pancreatic or periampullary cancer * Signed Informed consent Exclusion Criteria: * Metastatic or unresectable disease found preoperatively * Comorbidities contraindicating prehabilitation regimen (exercise and nutritional intervention) such as orthopedic, cognitive disabilities, chronic renal failure (dialysis or creatinine \>250 mmol) * ASA score 4-5 * Pregnancy * Illiteracy (inability to read and understand Italian language)
Where this trial is running
Milan, Lombardy
- San Raffaele Hospital — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Nicolò Pecorelli, MD
- Email: pecorelli.nicolo@hsr.it
- Phone: +390226432111
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.