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

Fresenius Kabi17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Cachexia Cancer

Interventions

oral nutritional supplement, food for special medical purposesDIETARY_SUPPLEMENT

2 servings of 200-300 ml per day, treatment period: 16 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Dipartimento di Medicina Clinica, La Sapienza Università, Rome

Rome, Italy

Indywidualna Specjalistyczna Praktyka lekarska

Ruda Śląska, Poland

Pulmonology Dept. of Miedzylesie Hospital

Warsaw, Poland