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

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

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.

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