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

Fresenius Kabi

Status

Terminated

Conditions

Cachexia

Cancer

Treatments

Dietary Supplement: oral nutritional supplement, food for special medical purposes

Study type

Interventional

Funder types

Industry

Identifiers

NCT00851448

PCSU-001-CFS

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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