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Completed

NCT Number: NCT00919659

Parenteral Nutrition Support for Patients With Pancreatic Cancer

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.

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Key information

Conditions

Cancer Cachexia Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hyperphagia Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsmedizin Berlin - Charité

Berlin, State of Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histological proved pancreatic cancer
  • progressive cancer cachexia
  • refractive to enteral supplementation
  • informed consent

Exclusion criteria

  • prefinal status
  • septic disease

Treatment and study plan

parenteral nutrition

Dietary Supplement

25kcal/kg bw with parenteral nutrition

Other names: no specific brand name

Primary outcomes

  1. nutritional status presented by phase angle

    Time frame: 12 weeks

Secondary outcomes

  1. quantity of port infections, quantity of oedema, quantity of diarrhea

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

CONKO-Studiengruppe

Other

Collaborators

  • Fresenius AG

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jun 12, 2009
Registry last updated
Jun 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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