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

This study is currently recruiting participants.
Verified January 2013 by National Center for Tumor Diseases, Heidelberg
Sponsor:
Collaborator:
University of Heidelberg
Information provided by (Responsible Party):
National Center for Tumor Diseases, Heidelberg
ClinicalTrials.gov Identifier:
NCT01362582
First received: November 25, 2010
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Pancreatic Cancer
 Drug: SMOF Kabiven
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Tumor Diseases, Heidelberg:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 120
Study Start Date: March 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362582

Contacts
Contact: Lutz Schneider, Dr. + 49 6221 56 38072 lutz.schneider@med.uni-heidelberg.de

Locations
Germany
Onkologische Schwerpunktpraxis und Tagesklinik Recruiting
Bad Soden, Germany, 65812
Contact: Gernot Seipelt, PD Dr.     06196657660     G.Seipelt@telemed.de    
Principal Investigator: Gernot Seipelt, PD Dr.            
Universitätsklinikum Erlangen Withdrawn
Erlangen, Germany, 91054
Krankenhaus Nordwest Frankfurt Recruiting
Frankfurt am Main, Germany, 60488
Contact: Elke Jäger, Prof. Dr.     06976013340     jaeger.elke@khnw.de    
Principal Investigator: Elke Jäger, Prof. Dr.            
University Hospital of Heidelberg / National Center for Tumordiseases Recruiting
Heidelberg, Germany, 69120
Contact: Lutz Schneider, Dr.     + 49 6221 56 38072     lutz.schneider@med.uni-heidelberg.de    
Contact: Beate Mosl, Dr.     + 49 6221 56 37174     beate.mosl@med.uni-heidelberg.de    
Sub-Investigator: Lutz Schneider, Dr.            
Universityhospital Marburg Withdrawn
Marburg, Germany, 35033
University hospital Ulm Withdrawn
Ulm, Germany, 89081
Asklepios Klinik Weißenfels Recruiting
Weißenfels, Germany, 06667
Contact: Gabriele Triebkorn, Dr.     03443401218        
Principal Investigator: Gabriele Triebkorn, Dr.            
Sponsors and Collaborators
National Center for Tumor Diseases, Heidelberg
University of Heidelberg
Investigators
Principal Investigator: Dirk Jäger, Prof. Dr. University of Heidelberg / National Center for Tumordiseases
  More Information

Publications:

Responsible Party: National Center for Tumor Diseases, Heidelberg
ClinicalTrials.gov Identifier: NCT01362582     History of Changes
Other Study ID Numbers: NCT-2008-11-03-1018, 60516908
Study First Received: November 25, 2010
Last Updated: January 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by National Center for Tumor Diseases, Heidelberg:
Pancreatic cancer
progression under chemotherapy
parenteral nutrition
pancreatic adenocarcinoma
chemotherapy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013