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

September 24, 2014 updated by: National Center for Tumor Diseases, Heidelberg

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Soden, Germany, 65812
        • Onkologische Schwerpunktpraxis und Tagesklinik
      • Frankfurt am Main, Germany, 60488
        • Krankenhaus Nordwest Frankfurt
      • Heidelberg, Germany, 69120
        • University Hospital of Heidelberg / National Center for Tumordiseases
      • Weißenfels, Germany, 06667
        • Asklepios Klinik Weissenfels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire EORTC - Quality of Life
Time Frame: 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)
every 1st and 22nd day of a cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of nutritional status
Time Frame: 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)
every 1st and 22nd day of a cycle)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Tumor Diseases, Heidelberg

Collaborators

Heidelberg University

Investigators

  • Principal Investigator: Dirk Jäger, Prof. Dr., University of Heidelberg / National Center for Tumordiseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 25, 2010

First Submitted That Met QC Criteria

May 27, 2011

First Posted (Estimate)

May 30, 2011

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT-2008-11-03-1018
  • 60516908 (Registry Identifier: ISRCTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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