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

NCT ID: NCT01362582

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-09-30

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?

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

SMOF Kabiven

Intervention Type: DRUG

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

Interventions

SMOF Kabiven

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: collaborator

National Center for Tumor Diseases, Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk Jäger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Heidelberg / National Center for Tumordiseases

Locations

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

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 19943918 (View on PubMed)

Other Identifiers

60516908

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCT-2008-11-03-1018

Identifier Type: -

Identifier Source: org_study_id