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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00851448
• Other study ID #: PCSU-001-CFS
• Status: Terminated
• Phase: N/A
• First received: February 13, 2009
• Last updated: June 1, 2011
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cachexia
• Cancer

Intervention

Dietary Supplement:
• oral nutritional supplement, food for special medical purposes
2 servings of 200-300 ml per day, treatment period: 16 weeks

Locations

Country	Name	City	State
Italy	Dipartimento di Medicina Clinica, La Sapienza Università, Rome	Rome
Poland	Indywidualna Specjalistyczna Praktyka lekarska	Ruda Slaska
Poland	Pulmonology Dept. of Miedzylesie Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Countries where clinical trial is conducted

Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compliance to nutrition therapy		baseline, months 1, 2, 3, 4	No
Secondary	anorexia questionnaire		baseline, months 1, 2, 3, 4	No
Secondary	gastrointestinal syndrome score (GIS)		baseline, months 1, 2, 3, 4	No
Secondary	body cell mass		baseline, months 1, 2, 3, 4	No
Secondary	weight change		baseline, months 1, 2, 3, 4	No
Secondary	hand grip strength		baseline, months 1, 2, 3, 4	No
Secondary	ECOG performance status		baseline, months 1, 2, 3, 4	No