Parenteral Nutrition Support for Patients With Pancreatic... | NCT00919659

Studies
Parenteral Nutrition Support for Patients With Pancreatic Cancer

NCT00919659

Sponsor

CONKO-Studiengruppe

Status

Completed

Last Update Posted

Jun 12, 2009Estimated

Enrollment

32Actual

Phase

Phase 2

Conditions

Cancer Cachexia
Pancreatic Cancer

Interventions

parenteral nutrition

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Jan 2004Actual

Completion Date

May 2004Actual

First Submitted Date

Jun 9, 2009

First Submission Date that Met QC Criteria

Jun 11, 2009

First Posted Date

Jun 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2009

Last Update Posted Date

Jun 12, 2009Estimated

Name	Class
Fresenius AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
parenteral nutrition	Experimental	25kcal/kg/bw /day via parenteral support	Dietary Supplement: parenteral nutrition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
parenteral nutrition	Dietary Supplement	25kcal/kg bw with parenteral nutrition	parenteral nutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
nutritional status presented by phase angle		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
quantity of port infections, quantity of oedema, quantity of diarrhea		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

prefinal status
septic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
helmut oettle, MD	CONKO-Studiengruppe	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsmedizin Berlin - Charité		Berlin	State of Berlin	13353	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20214798	Derived	Pelzer U, Arnold D, Govercin M, Stieler J, Doerken B, Riess H, Oettle H. Parenteral nutrition support for patients with pancreatic cancer. Results of a phase II study. BMC Cancer. 2010 Mar 9;10:86. doi: 10.1186/1471-2407-10-86.

ID	Term
D010190	Pancreatic Neoplasms
D006963	Hyperphagia

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy