Clinical trial · Interventional
Prehabilitation in Pancreatic Surgery
Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In patients with pancreatic cancer, older age, multiple comorbidities, frailty, malnutrition and poor functional status are common, especially in individuals receiving neoadjuvant chemotherapy. These characteristics represent potentially modifiable risk factors for poor postoperative outcomes. The goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative morbidity, functional and nutritional status and health-related quality of life in patients with localized pancreatic or periampullary cancer scheduled for curative surgery. In addition, the impact of prehabilitation on circulating sarcopenia and cancer cachexia biomarkers in PDAC patients will be explored. Included patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation), which will receive prehabilitation, or to the control group, which will receive no prehabilitation.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Frailty Syndrome | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Periampullary Cancer | Periampullary Adenocarcinoma | ALIAS | 0.90 |
| Perioperative/Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Prehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multimodal Prehabilitation
- description
- The intervention consists of a supervised multimodal prehabilitation program (exercise, nutritional support, and psychosocial counseling) conducted for a minimum of four weeks prior to surgery, during the waiting time following patient enrolment.
- interventionNames
- Other: Multimodal Prehabilitation
- type
- NO_INTERVENTION
- label
- Usual care
- description
- Usual preoperative care. Patients in the control group will be treated according to usual care and will be given informative material regarding a healthy lifestyle and how to best prepare for surgery.
Primary outcomes (1)
- measure
- Comprehensive Complication Index (CCI)
- timeFrame
- 90 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (4)
- BACKGROUNDMizrahi JD, Surana R, Valle JW, Shroff RT. Pancreatic cancer. Lancet. 2020 Jun 27;395(10242):2008-2020. doi: 10.1016/S0140-6736(20)30974-0. PMID 32593337
- BACKGROUNDLambert JE, Hayes LD, Keegan TJ, Subar DA, Gaffney CJ. The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. Ann Surg. 2021 Jul 1;274(1):70-77. doi: 10.1097/SLA.0000000000004527. PMID 33201129
- BACKGROUNDPecorelli N, Guarneri G, Vallorani A, Limongi C, Licinio AW, Di Salvo F, Tamburrino D, Partelli S, Crippa S, Falconi M. Validation of the PROMIS-29 Questionnaire as a Measure of Recovery After Pancreatic Surgery. Ann Surg. 2023 Nov 1;278(5):732-739. doi: 10.1097/SLA.0000000000006020. Epub 2023 Jul 19. PMID 37465965
- DERIVEDPecorelli N, Fermi F, Abati M, Bonomi B, Fossati L, Corti G, Guarneri G, Macchini M, Damascelli A, Palumbo D, Gaviraghi S, Di Mattei V, De Cobelli F, Tettamanti A, Falconi M. Multimodal Prehabilitation In Pancreatic cancer Patients undergoing surgery (PIPS): study protocol for a randomized controlled trial. Trials. 2026 Jan 31;27(1):184. doi: 10.1186/s13063-026-09467-z. PMID 41618415