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NCT00919659 Clinical Trial

Parenteral Nutrition Support for Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:
Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00919659
Other study ID # C25.0
Secondary ID
Status Completed
Phase Phase 2
First received June 9, 2009
Last updated June 11, 2009
Start date January 2002
Est. completion date May 2004

Study information
Verified date June 2009
Source CONKO-Studiengruppe
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesGermany: Federal Ministry of Education and Research
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.

Description:

To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date May 2004
Est. primary completion date January 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- histological proved pancreatic cancer

- progressive cancer cachexia

- refractive to enteral supplementation

- informed consent

Exclusion Criteria:

- prefinal status

- septic disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• parenteral nutrition
25kcal/kg bw with parenteral nutrition

Locations
Country Name City State
Germany Universitätsmedizin Berlin - Charité Berlin

Sponsors (2)
Lead Sponsor Collaborator
CONKO-Studiengruppe Fresenius AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary nutritional status presented by phase angle 12 weeks No
Secondary quantity of port infections, quantity of oedema, quantity of diarrhea 12 weeks Yes
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