Effects of Peptamen 1.6 in Malnourished Patients (or At Risk) with Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): a Mechanistic Study

Launched by FUNDACIÓN PÚBLICA ANDALUZA PARA LA INVESTIGACIÓN DE MÁLAGA EN BIOMEDICINA Y SALUD · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a special nutritional drink called Peptamen 1.6 affects malnourished patients with pancreatic cancer who have recently undergone surgery known as cephalic pancreaticoduodenectomy (CPD). The goal is to see if Peptamen 1.6 can improve their nutritional status, help their bodies heal better, and support their digestive health compared to another nutritional formula. The study will look at various factors, including how well participants absorb nutrients, their overall health, inflammation levels, and changes in gut bacteria.

To be eligible for this trial, participants should be ambulatory (able to move around), malnourished or at risk of malnutrition, and diagnosed with pancreatic cancer, having had the CPD surgery within the last three months. They should not have received any chemotherapy or radiation before this surgery, as these treatments can affect the results of the study. Participants will be closely monitored throughout the trial, and they can expect to undergo various tests to measure their health and how well they tolerate the nutritional drink. This research aims to improve nutritional support for patients after surgery, potentially leading to better recovery outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ambulatory patients who are malnourished or at risk of malnutrition, with a confirmed diagnosis of pancreatic cancer and who have undergone cephalic pancreaticoduodenectomy (CPD).
• • No prior neoadjuvant treatment (preoperative chemotherapy or radiotherapy): Patients must not have received neoadjuvant therapy as these treatments can affect metabolism, nutritional status, and gut microbiota, potentially interfering with the objectives of the study's nutritional intervention.
• Exclusion Criteria:
• • Refusal to sign informed consent: Informed consent is a mandatory requirement for study participation. Any patient unwilling to participate voluntarily will be excluded.
• • Intervention performed more than 90 days prior to the baseline visit: Patients who underwent surgery more than three months ago will be excluded, as the nutritional intervention must begin in the immediate postoperative period to adequately evaluate its impact on nutritional and metabolic status.
• • Presence of severe cardiac disease, nephropathy, or other severe comorbidities: Conditions such as severe cardiac disease, renal failure, or comorbidities that could induce malnutrition or impair the patient's ability to tolerate nutritional treatment will be exclusion criteria. These conditions may interfere with assessing the effects of nutritional supplementation in the context of pancreatic cancer treatment.
• • Diarrhoea associated with antibiotics, laxatives, or osmotically active agents: Diarrhoea caused by medications may alter nutrient absorption and affect tolerance to the nutritional supplement, potentially skewing results attributable solely to the nutritional intervention.
• • Treatment with other nutritional support: Patients receiving other oral nutritional supplement, enteral or parenteral nutrition will be excluded, as interactions with the studied formula could confound the efficacy results of the study's nutritional intervention.
• • Pregnancy or possibility of becoming pregnant.
• • Type 1 or Type 2 diabetes with HbA1c \>8%.
• • Galactosaemia, fructosaemia, or allergies to components of the nutritional supplement.