Clinical trialPhase 3Terminated
Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer
Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
- Outcome
- Stopped early
- Phase
- Phase 3
- Status
- Terminated
- Study type
- Interventional
- Start
- March 2010
- Expected end
- September 2014
- Enrollment
- 32 participants
- Sites
- 4
- Primary outcomes
- Questionnaire EORTC - Quality of Life
- Sponsor
- Other
- Results posted
- No
- Last update
- 25 September 2014
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Brief summary public domain (ClinicalTrials.gov)
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).
Detailed description public domain (ClinicalTrials.gov)
Pancreatic cancer is an extremely aggressive malignancy characterized by extensive invasion, early metastasis, and marked cachexia. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia and deterioration in performance status, even when their tumour burden is low. Therefore, one of the most important therapeutic targets is the improvement of quality of life. Supplementation with parenteral nutrition improves Quality of Life in subjects with advanced cancer cachexia. The European Society of Parenteral and Enteral Nutrition recommend PN only for malnourished subjects but does not reflect situation in cancer cachexia patients At present, no 2nd-line therapy (or higher) is recommended for pancreatic adenocarcinoma, but often asked for. Within this clinical trial, we evaluate if parenteral nutrition in combination with chemotherapy in subjects with advanced pancreatic adenocarcinoma have an impact on quality of life?