| NCT ID | NCT06069297 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 238 participants |
| Start Date | 2023-07-14 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 238 participants in total. It began in 2023-07-14 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Massimo Falconi, MD
STUDY CHAIR
San Raffaele Hospital
Frequently Asked Questions
Who can join the NCT06069297 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06069297 currently recruiting?
Yes, NCT06069297 is actively recruiting participants. Contact the research team at pecorelli.nicolo@hsr.it for enrollment information.
Where is the NCT06069297 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06069297 clinical trial?
NCT06069297 is sponsored by IRCCS San Raffaele. The principal investigator is Massimo Falconi, MD at San Raffaele Hospital. The trial plans to enroll 238 participants.
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