Status:
TERMINATED
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients
Lead Sponsor:
Fresenius Kabi
Conditions:
Cachexia
Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00851448
Start Date
October 1 2009
End Date
April 1 2011
Last Update
June 2 2011
Active Locations (3)
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1
Dipartimento di Medicina Clinica, La Sapienza Università, Rome
Rome, Italy, I- 00185
2
Indywidualna Specjalistyczna Praktyka lekarska
Ruda Śląska, Poland, 41-709
3
Pulmonology Dept. of Miedzylesie Hospital
Warsaw, Poland, PL-04-749