Peptamen 1.6 versus Resource HP/HC for nutrition after cephalic pancreaticoduodenectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, crossover trial comparing a peptide-based enteral formula (Peptamen 1.6) with a polymeric high-protein/high-calorie formula (Resource HP/HC) in ambulatory patients who are malnourished or at risk after cephalic pancreaticoduodenectomy. In the in vivo arm, participants receive both formulas in sequence and investigators measure digestive tolerance, amino acid absorption, nutritional status, metabolic and inflammatory markers, and changes in gut microbiota. The in vitro component uses human intestinal organoids to examine how the different formulations affect intestinal permeability and related cellular mechanisms. The trial enrols patients within the immediate postoperative period and excludes those who received neoadjuvant therapy to avoid confounding effects on metabolism and microbiota.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ambulatory patients who are malnourished or at risk of malnutrition, with a confirmed diagnosis of neoplasms of the periampullary region, pancreas, and duodenum, or 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.
* 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.

Where it's running

• Hospital Regional Universitario de Málaga
  Málaga, Málaga, Spain Recruiting

Study contacts

• Principal investigator: Gabriel Olveira Fuster, MD, PhD — Hospital Regional Universitario de Málaga, FIMABIS
• Study coordinator: Gabriel Olveira Fuster, MD, PhD
• Email: gabrielm.olveira.sspa@juntadeandalucia.es
• Phone: 951290343

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BEFAST: Total Body PET/CT with Ga-68 FAPI for Better Imaging in Cancer

  This study tests whether Ga-68 FAPI-46 Total Body PET/CT can better detect cancer spread and provide fast, clear images for adults with pancreatic or gastroesophageal cancer.

  Recruiting Phase 2 Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT07629609

• Chronic Stress and Pancreatic Cancer Outcomes in People with Pancreatic Cancer

  This study tests whether ongoing psychological stress affects how pancreatic cancer behaves and responds to treatment in adults.

  Recruiting Shanghai Zhongshan Hospital · Changsha, Hunan and 2 other locations · NCT07529626

• Prehab to get stronger before pancreatic cancer surgery

  This project will test whether adults with pancreatic cancer can follow a combined exercise, nutrition, and symptom-management program during chemotherapy to improve fitness and recovery before surgery.

  Recruiting University of Massachusetts, Worcester · Worester, Massachusetts · NCT07478185

• Surufatinib with Gemcitabine and Nab-paclitaxel as Neoadjuvant Therapy for High-Risk or Borderline Resectable Pancreatic Cancer

  This trial tests whether adding surufatinib to gemcitabine and nab-paclitaxel before surgery helps adults with high-risk resectable or borderline resectable pancreatic cancer.

  Recruiting Phase 3 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07436741

• Using deep learning and Raman spectroscopy for early cancer diagnosis

  This study is trying to see if a new deep learning tool using blood samples can help spot early signs of different types of cancer, like colorectal and gastric cancers, in both healthy people and those already diagnosed.

  Recruiting at 4 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Nanchang, Jiangxi and 3 other locations · NCT06822413

• Monitoring pancreatic health after a new diabetes diagnosis

  We will try a new blood test called Avantect to see if it can detect early pancreatic cancer in people aged 50–84 who were diagnosed with type 2 diabetes within the past six months.

  Recruiting at 22 sites University Hospital Southampton NHS Foundation Trust · Sandbach, Cheshire and 30 other locations · NCT06803771

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.