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

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ClinicalTrials.gov Identifier: NCT00851448
Recruitment Status : Terminated
First Posted : February 26, 2009
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cachexia Cancer Dietary Supplement: oral nutritional supplement, food for special medical purposes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. compliance to nutrition therapy [ Time Frame: baseline, months 1, 2, 3, 4 ]

Secondary Outcome Measures :
  1. anorexia questionnaire [ Time Frame: baseline, months 1, 2, 3, 4 ]
  2. gastrointestinal syndrome score (GIS) [ Time Frame: baseline, months 1, 2, 3, 4 ]
  3. body cell mass [ Time Frame: baseline, months 1, 2, 3, 4 ]
  4. weight change [ Time Frame: baseline, months 1, 2, 3, 4 ]
  5. hand grip strength [ Time Frame: baseline, months 1, 2, 3, 4 ]
  6. ECOG performance status [ Time Frame: baseline, months 1, 2, 3, 4 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851448


Locations
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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
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Principal Investigator: Filippo Rossi-Fanelli, Professor La Sapienza Università, Rome

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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
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms