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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01362582
Other study ID # NCT-2008-11-03-1018
Secondary ID 60516908
Status Terminated
Phase Phase 3
First received November 25, 2010
Last updated September 24, 2014
Start date March 2010
Est. completion date September 2014

Study information

Verified date September 2014
Source National Center for Tumor Diseases, Heidelberg
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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).


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?


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date September 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
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 Asklepios Klinik Weißenfels Weißenfels

Sponsors (2)

Lead Sponsor Collaborator
National Center for Tumor Diseases, Heidelberg Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Märten A, Wente MN, Ose J, Büchler MW, Rötzer I, Decker-Baumann C, Karapanagiotou-Schenkel I, Harig S, Schmidt J, Jäger 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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) No
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