Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients

This study has been terminated.

Sponsor:

Information provided by:

Fresenius Kabi

ClinicalTrials.gov Identifier:

NCT00851448

First received: February 13, 2009

Last updated: June 1, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 13, 2009

Last Updated Date

June 1, 2011

Start Date ^ICMJE

October 2009

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

compliance to nutrition therapy [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00851448 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

anorexia questionnaire [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
gastrointestinal syndrome score (GIS) [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
body cell mass [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
weight change [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
hand grip strength [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]
ECOG performance status [ Time Frame: baseline, months 1, 2, 3, 4 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients

Official Title ^ICMJE

Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients. A Randomised, Double-blind, Controlled Pilot Study

Brief Summary

To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in lung cancer patients.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Cachexia
Cancer

Intervention ^ICMJE

Dietary Supplement: oral nutritional supplement, food for special medical purposes

2 servings of 200-300 ml per day, treatment period: 16 weeks

Study Arm (s)

Experimental: 1
Oral nutritional supplement containing n-3 fatty acids, amino acids, antioxidants

Intervention: Dietary Supplement: oral nutritional supplement, food for special medical purposes
Placebo Comparator: 2
isocaloric, isonitrogenous

Intervention: Dietary Supplement: oral nutritional supplement, food for special medical purposes

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

non-small cell lung cancer patients stage IIIb or IV
planned chemotherapy or combined chemo-/radiotherapy
current body weight less than 6 months ago
abnormal CRF level
BMI >=20 kg/m2 and <=30kg/m2

Exclusion Criteria:

significant oedema in the time of screening and randomisation
concomitant inflammatory diseases
active infections including HIV and AIDS
liver failure
chronic renal failure or cardiac pacemaker
chronic heart failure
insulin treated diabetes mellitus
medications that impair sex hormone synthesis, secretion or function
acute or chronic infections
body weight loss > 5% during the last 6 months or > 10% during the last 10 months
fish oil supplementation within 3 months prior to study entry
taking vitamins in doses greater than recommended daily allowance
life expectancy less than 6 months in the opinion of the investigator

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy, Poland

Administrative Information

NCT Number ^ICMJE

NCT00851448

Other Study ID Numbers ^ICMJE

PCSU-001-CFS

Has Data Monitoring Committee

Not Provided

Responsible Party

Dr. Ericka Pestana, I&D Clinical Nutrition & Pharmaceuticals, SP&T, Fresenius Kabi Deutschland GmbH

Study Sponsor ^ICMJE

Fresenius Kabi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Filippo Rossi-Fanelli, Professor

La Sapienza Università, Rome

Information Provided By

Fresenius Kabi

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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