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

Phase 3

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: SMOF Kabiven

• Registration Number: NCT01362582
• Lead Sponsor: National Center for Tumor Diseases, Heidelberg

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?

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-11-25
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-05-30
• Primary Completion: 2014-08
• Status Verified: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PN, Chemotherapy, Nutritional Care	SMOF Kabiven	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

Primary Outcome Measures

Name	Time	Method
Questionnaire EORTC - Quality of Life	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)

Secondary Outcome Measures

Name	Time	Method
Assessment of nutritional status	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)

Trial Locations

Locations (4)

Asklepios Klinik Weißenfels; 🇩🇪 Weißenfels, Germany

Onkologische Schwerpunktpraxis und Tagesklinik; 🇩🇪 Bad Soden, Germany

Krankenhaus Nordwest Frankfurt; 🇩🇪 Frankfurt am Main, Germany

University Hospital of Heidelberg / National Center for Tumordiseases; 🇩🇪 Heidelberg, Germany