Clinical trial NCT01362582: Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer
Official title: Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
progression under chemotherapy
parenteral nutrition
pancreatic adenocarcinoma
chemotherapy
Lead sponsor: National Center for Tumor Diseases, Heidelberg
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2011-05-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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

Primary outcomes:
measure: Questionnaire EORTC - Quality of Life
timeFrame: every 1st and 22nd day of a cycle
Secondary outcomes:
measure: Assessment of nutritional status
timeFrame: every 1st and 22nd day of a cycle)
Other outcomes:
Locations:
city: Bad Soden
country: Germany
facility: Onkologische Schwerpunktpraxis und Tagesklinik
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest Frankfurt
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg / National Center for Tumordiseases
city: Weißenfels
country: Germany
facility: Asklepios Klinik Weißenfels
Study officials:
affiliation: University of Heidelberg / National Center for Tumordiseases
name: Dirk Jäger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marten A, Wente MN, Ose J, Buchler MW, Rotzer I, Decker-Baumann C, Karapanagiotou-Schenkel I, Harig S, Schmidt J, Jager D. An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO. BMC Cancer. 2009 Nov 27;9:412. doi: 10.1186/1471-2407-9-412.