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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by National Center for Tumor Diseases, Heidelberg
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
National Center for Tumor Diseases, Heidelberg
ClinicalTrials.gov Identifier:
NCT01362582
First received: November 25, 2010
Last updated: August 21, 2013
Last verified: August 2013

November 25, 2010
August 21, 2013
March 2010
January 2015   (final data collection date for primary outcome measure)
Questionnaire EORTC - Quality of Life [ Time Frame: every 1st and 22nd day of a cycle ] [ Designated as safety issue: No ]

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)
Same as current
Complete list of historical versions of study NCT01362582 on ClinicalTrials.gov Archive Site
Assessment of nutritional status [ Time Frame: every 1st and 22nd day of a cycle) ] [ Designated as safety issue: No ]
  • 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)
Same as current
Not Provided
Not Provided
 
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

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).

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?

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
Drug: SMOF Kabiven
SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml.
  • No Intervention: Chemotherapy, Nutritional Care

    5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43.

    Subjects in the control group receive Best Supportive Nutritional Care. BSNC is defined as nutritional consultation and recommendation by experienced ecotrophologists.

  • Experimental: PN, Chemotherapy, Nutritional Care

    5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43.

    Patients receive also Best Supportive Nutritional Care defined as nutritional consultation and recommendation by experienced ecotrophologists.

    Intervention: Supportive Parenteral Nutrition

    Intervention: Drug: SMOF Kabiven
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
July 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Lutz Schneider, Dr. + 49 6221 56 38072 lutz.schneider@med.uni-heidelberg.de
Germany
 
NCT01362582
NCT-2008-11-03-1018, 60516908
Yes
National Center for Tumor Diseases, Heidelberg
National Center for Tumor Diseases, Heidelberg
Heidelberg University
Principal Investigator: Dirk Jäger, Prof. Dr. University of Heidelberg / National Center for Tumordiseases
National Center for Tumor Diseases, Heidelberg
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP