Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer (PANUSCO)
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, progression under chemotherapy, parenteral nutrition, pancreatic adenocarcinoma, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Histological confirmed advanced pancreatic adenocarcinoma
- At least one previous chemotherapy (gemcitabine-based)
- ≥ 18 years old
- Body weight ≥ 50 and ≤ 95 kg
- BMI ≥ 19
- Negative pregnancy test (females of childbearing potential)
- Willingness to perform double-barrier contraception during study
- Expected life expectancy > 3 months
Exclusion Criteria:
- Major surgery < 4 weeks prior to enrollment
- Weight loss > 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days
- PINI-Index > 10
- Pregnancy or breastfeeding
- > 4 weeks of parenteral nutrition within the last 6 months
- Parenteral nutrition < 4 weeks prior to enrollment
- Vulnerable populations (e.g. subjects incapable of giving consent personally)
- Subject selection conflicts with warnings, precautions and contraindications stated for any investigational product
Sites / Locations
- Onkologische Schwerpunktpraxis und Tagesklinik
- Krankenhaus Nordwest Frankfurt
- University Hospital of Heidelberg / National Center for Tumordiseases
- Asklepios Klinik Weißenfels
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Chemotherapy, Nutritional Care
PN, Chemotherapy, Nutritional Care
5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43. Subjects in the control group receive Best Supportive Nutritional Care. BSNC is defined as nutritional consultation and recommendation by experienced ecotrophologists.
5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43. Patients receive also Best Supportive Nutritional Care defined as nutritional consultation and recommendation by experienced ecotrophologists. Intervention: Supportive Parenteral Nutrition