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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
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients. A Randomised, Double-blind, Controlled Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fresenius Kabi:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral nutritional supplement containing n-3 fatty acids, amino acids, antioxidants
 Dietary Supplement: oral nutritional supplement, food for special medical purposes
2 servings of 200-300 ml per day, treatment period: 16 weeks
Placebo Comparator: 2
isocaloric, isonitrogenous
 Dietary Supplement: oral nutritional supplement, food for special medical purposes
2 servings of 200-300 ml per day, treatment period: 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851448

Locations
Italy
Dipartimento di Medicina Clinica, La Sapienza Università, Rome
Rome, Italy, I- 00185
Poland
Indywidualna Specjalistyczna Praktyka lekarska
Ruda Slaska, Poland, 41-709
Pulmonology Dept. of Miedzylesie Hospital
Warsaw, Poland, PL-04-749
Sponsors and Collaborators
Fresenius Kabi
Investigators
Principal Investigator: Filippo Rossi-Fanelli, Professor La Sapienza Università, Rome
  More Information

No publications provided

Responsible Party: Dr. Ericka Pestana, I&D Clinical Nutrition & Pharmaceuticals, SP&T, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00851448     History of Changes
Other Study ID Numbers: PCSU-001-CFS
Study First Received: February 13, 2009
Last Updated: June 1, 2011
Health Authority: Poland: Ethics Committee

Additional relevant MeSH terms:
Cachexia
Lung Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013