Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients. A Randomised, Double-blind, Controlled Pilot Study
N/A
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Cachexia, Cancer
Both
Cachexia, Cancer
Trial Information
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients. A Randomised, Double-blind, Controlled Pilot Study
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
compliance to nutrition therapy
Outcome Time Frame:
baseline, months 1, 2, 3, 4
Safety Issue:
No
Principal Investigator
Filippo Rossi-Fanelli, Professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
La Sapienza Università, Rome
Authority:
Poland: Ethics Committee
Study ID:
PCSU-001-CFS
NCT ID:
NCT00851448
Start Date:
October 2009
Completion Date:
April 2011
Related Keywords:
- Cachexia
- Cancer
- Cachexia
- Lung Neoplasms
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