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

NCT00851448 | Terminated

• 1 other identifier: PCSU-001-CFS
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cachexia; Cancer

Outcome Measures

Primary Outcomes (1)

• compliance to nutrition therapy

  baseline, months 1, 2, 3, 4

Secondary Outcomes (6)

• 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

Study Arms (2)

1

EXPERIMENTAL

Oral nutritional supplement containing n-3 fatty acids, amino acids, antioxidants

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

2

PLACEBO COMPARATOR

isocaloric, isonitrogenous

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

Interventions

oral nutritional supplement, food for special medical purposes DIETARY_SUPPLEMENT

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

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (3)

Dipartimento di Medicina Clinica, La Sapienza Università, Rome

Rome, I- 00185, Italy

Location

Indywidualna Specjalistyczna Praktyka lekarska

Ruda Śląska, 41-709, Poland

Location

Pulmonology Dept. of Miedzylesie Hospital

Warsaw, PL-04-749, Poland

Location

MeSH Terms

Conditions

Cachexia; Neoplasms

Interventions

Dietary Supplements; Food

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Filippo Rossi-Fanelli, Professor

  La Sapienza Università, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 26, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 2, 2011

Record last verified: 2011-05

Locations

IT (1); PL (2)