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.

Study Overview

• Status: Terminated
• Conditions: Cancer; Cachexia
• Intervention / Treatment: Dietary supplement: oral nutritional supplement, food for special medical purposes

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, I- 00185
    • Dipartimento di Medicina Clinica, La Sapienza Università, Rome
• Poland
  • Ruda Slaska, Poland, 41-709
    • Indywidualna Specjalistyczna Praktyka Lekarska
  • Warsaw, Poland, PL-04-749
    • Pulmonology Dept. of Miedzylesie Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
anorexia questionnaire	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
gastrointestinal syndrome score (GIS)	baseline, months 1, 2, 3, 4
ECOG performance status	baseline, months 1, 2, 3, 4

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Principal Investigator: Filippo Rossi-Fanelli, Professor, La Sapienza Università, Rome

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: February 25, 2009
• First Posted (Estimate): February 26, 2009

Study Record Updates

• Last Update Posted (Estimate): June 2, 2011
• Last Update Submitted That Met QC Criteria: June 1, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Emaciation; Weight Loss; Cachexia
• Other Study ID Numbers: PCSU-001-CFS