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

Phase 3TerminatedNCT01362582

National Center for Tumor Diseases, Heidelberg32 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

SMOF KabivenDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Onkologische Schwerpunktpraxis und Tagesklinik

Bad Soden, Germany

Krankenhaus Nordwest Frankfurt

Frankfurt am Main, Germany

University Hospital of Heidelberg / National Center for Tumordiseases

Heidelberg, Germany

Asklepios Klinik Weißenfels

Weißenfels, Germany

Outcomes

Primary Outcomes

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)

Time frame: every 1st and 22nd day of a cycle

Secondary Outcomes

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)

Time frame: every 1st and 22nd day of a cycle)

Data from ClinicalTrials.gov

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