Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
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?
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Questionnaire EORTC - Quality of Life
Outcome Description:
The following questionnaires will be given to subjects: EORTC QLQ-C30 (every 1st and 22nd day of a cycle) EORTC QLQ Pan-26 (every 1st and 22nd day of a cycle)
Outcome Time Frame:
every 1st and 22nd day of a cycle
Safety Issue:
No
Principal Investigator
Dirk Jäger, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Heidelberg / National Center for Tumordiseases
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
NCT-2008-11-03-1018
NCT ID:
NCT01362582
Start Date:
March 2010
Completion Date:
July 2015
Related Keywords:
- Pancreatic Cancer
- Pancreatic cancer
- progression under chemotherapy
- parenteral nutrition
- pancreatic adenocarcinoma
- chemotherapy
- Pancreatic Neoplasms
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