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

Pancreatic Cancer Clinical Trial

— PANUSCO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01362582
• Other study ID #: NCT-2008-11-03-1018
• Secondary ID: 60516908
• Status: Terminated
• Phase: Phase 3
• First received: November 25, 2010
• Last updated: September 24, 2014
• Start date: March 2010
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: National Center for Tumor Diseases, Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• SMOF Kabiven
SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml.

Locations

Country	Name	City	State
Germany	Onkologische Schwerpunktpraxis und Tagesklinik	Bad Soden
Germany	Krankenhaus Nordwest Frankfurt	Frankfurt am Main
Germany	University Hospital of Heidelberg / National Center for Tumordiseases	Heidelberg
Germany	Asklepios Klinik Weißenfels	Weißenfels

Sponsors (2)

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

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Märten A, Wente MN, Ose J, Büchler MW, Rötzer I, Decker-Baumann C, Karapanagiotou-Schenkel I, Harig S, Schmidt J, Jäger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire EORTC - Quality of Life	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)	every 1st and 22nd day of a cycle	No
Secondary	Assessment of nutritional status	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)	every 1st and 22nd day of a cycle)	No