Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Tumor Diseases, Heidelberg
• Collaborator: Heidelberg University

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