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

Study Overview
=================
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.

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

Conditions
-----------------
Cachexia, Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: oral nutritional supplement, food for special medical purposes


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral nutritional supplement containing n-3 fatty acids, amino acids, antioxidants | Dietary Supplement: oral nutritional supplement, food for special medical purposes<br>* 2 servings of 200-300 ml per day, treatment period: 16 weeks<br>|
| Placebo Comparator: 2<br>isocaloric, isonitrogenous | Dietary Supplement: oral nutritional supplement, food for special medical purposes<br>* 2 servings of 200-300 ml per day, treatment period: 16 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance to nutrition therapy |  | baseline, months 1, 2, 3, 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anorexia questionnaire |  | baseline, months 1, 2, 3, 4 | 
| gastrointestinal syndrome score (GIS) |  | baseline, months 1, 2, 3, 4 | 
| body cell mass |  | baseline, months 1, 2, 3, 4 | 
| weight change |  | baseline, months 1, 2, 3, 4 | 
| hand grip strength |  | baseline, months 1, 2, 3, 4 | 
| ECOG performance status |  | baseline, months 1, 2, 3, 4 |