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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
SMOF Kabiven
Sponsored by
National Center for Tumor Diseases, Heidelberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, progression under chemotherapy, parenteral nutrition, pancreatic adenocarcinoma, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Onkologische Schwerpunktpraxis und Tagesklinik
  • Krankenhaus Nordwest Frankfurt
  • University Hospital of Heidelberg / National Center for Tumordiseases
  • Asklepios Klinik Weißenfels

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Chemotherapy, Nutritional Care

PN, Chemotherapy, Nutritional Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
November 25, 2010
Last Updated
September 24, 2014
Sponsor
National Center for Tumor Diseases, Heidelberg
Collaborators
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01362582
Brief Title
Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Tumor Diseases, Heidelberg
Collaborators
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, progression under chemotherapy, parenteral nutrition, pancreatic adenocarcinoma, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy, Nutritional Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
PN, Chemotherapy, Nutritional Care
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
SMOF Kabiven
Intervention Description
SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml.
Primary Outcome Measure Information:
Title
Questionnaire EORTC - Quality of Life
Description
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)
Time Frame
every 1st and 22nd day of a cycle
Secondary Outcome Measure Information:
Title
Assessment of nutritional status
Description
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)
Time Frame
every 1st and 22nd day of a cycle)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Jäger, Prof. Dr.
Organizational Affiliation
University of Heidelberg / National Center for Tumordiseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onkologische Schwerpunktpraxis und Tagesklinik
City
Bad Soden
ZIP/Postal Code
65812
Country
Germany
Facility Name
Krankenhaus Nordwest Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Facility Name
University Hospital of Heidelberg / National Center for Tumordiseases
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Asklepios Klinik Weißenfels
City
Weißenfels
ZIP/Postal Code
06667
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19943918
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.
Results Reference
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Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer

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