Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, progression under chemotherapy, parenteral nutrition, pancreatic adenocarcinoma, chemotherapy
Brief 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).
Detailed description
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?
Interventions
DRUGSMOF Kabiven
SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml.
Sponsors
Heidelberg University
National Center for Tumor Diseases, Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire EORTC - Quality of Life | every 1st and 22nd day of a cycle | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of nutritional status | every 1st and 22nd day of a cycle) | * BIA: Phase angle, BCM and Extracellular Mass (ECM)/BCM ratio (every 1st and 22nd day of a cycle) * BMI (every 1st and 22nd day of a cycle) * Biceps size(every 1st and 22nd day of a cycle) * Hand-grip-strength(every 1st and 22nd day of a cycle) * PINI-Index (every 1st and 22nd day of a cycle) |
Countries
Germany
Outcome results
None listed