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NCT06069297Active, not recruiting

Prehabilitation in Pancreatic Surgery

Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
238 (estimated)
First submitted
25 Aug 2023
Start date
14 Jul 2023
Primary completion date
16 Dec 2026
Lead sponsor
IRCCS San Raffaele
NCT number
NCT06069297

What you commit to

  • Study type: Interventional
  • Planned participants: 238
  • From 14 Jul 2023 to the primary completion date, 16 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Metastatic or unresectable disease found preoperatively

Lab values

  • Comorbidities contraindicating prehabilitation regimen (exercise and nutritional intervention) such as orthopedic, cognitive disabilities, chronic renal failure (dialysis or creatinine \>250 mmol)

Other

  • ASA score 4-5
  • Pregnancy
  • Illiteracy (inability to read and understand Italian language)

Who the study is looking for

  • Age ≥ 18 years
  • Indication for curative resection for pancreatic or periampullary cancer
  • Signed Informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
San Raffaele Hospital
Coordinator of this site? Confirm its status
MilanItalyUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.