Comparing Parenteral Nutrition Vs Best Supportive Nutritional Care In Patients With Pancreatic Cancer

Study Overview

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

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?

Pancreatic Cancer

DRUG: SMOF Kabiven

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

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-11-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-09-24
First Submitted that Met QC Criteria 2011-05-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-09-25
First Posted (ESTIMATED) 2011-05-30	Results First Posted N/A	Last Verified 2014-09

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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

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

DRUG: SMOF Kabiven

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

EXPERIMENTAL: PN, Chemotherapy, Nutritional Care

DRUG: SMOF Kabiven

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

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame
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)

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Heidelberg University

Investigators

PRINCIPAL_INVESTIGATOR: Dirk Jäger, Prof. Dr., University of Heidelberg / National Center for Tumordiseases

Publications

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

General Publications

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.

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Clinical Trial Record