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

Not Applicable

Terminated

• Conditions: Cachexia; Cancer
• Interventions: Dietary Supplement: oral nutritional supplement, food for special medical purposes

• Registration Number: NCT00851448
• Lead Sponsor: Fresenius Kabi

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 available

Study Timeline

• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-25
• Study First Posted: 2009-02-26
• Study Start: 2009-10
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-06-01
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	oral nutritional supplement, food for special medical purposes	Oral nutritional supplement containing n-3 fatty acids, amino acids, antioxidants
2	oral nutritional supplement, food for special medical purposes	isocaloric, isonitrogenous

Primary Outcome Measures

Name	Time	Method
compliance to nutrition therapy	baseline, months 1, 2, 3, 4

Secondary Outcome Measures

Name	Time	Method
ECOG performance status	baseline, months 1, 2, 3, 4
anorexia questionnaire	baseline, months 1, 2, 3, 4
gastrointestinal syndrome score (GIS)	baseline, months 1, 2, 3, 4
body cell mass	baseline, months 1, 2, 3, 4
weight change	baseline, months 1, 2, 3, 4
hand grip strength	baseline, months 1, 2, 3, 4

Trial Locations

Locations (3)

Pulmonology Dept. of Miedzylesie Hospital; 🇵🇱 Warsaw, Poland

Dipartimento di Medicina Clinica, La Sapienza Università, Rome; 🇮🇹 Rome, Italy

Indywidualna Specjalistyczna Praktyka lekarska; 🇵🇱 Ruda Slaska, Poland