Back to resultsSafety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients
Primary Purpose
Cachexia, Cancer
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
oral nutritional supplement, food for special medical purposes
Sponsored by
About this trial
This is an interventional supportive care trial for Cachexia
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
Sites / Locations
- Dipartimento di Medicina Clinica, La Sapienza Università, Rome
- Indywidualna Specjalistyczna Praktyka lekarska
- Pulmonology Dept. of Miedzylesie Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Oral nutritional supplement containing n-3 fatty acids, amino acids, antioxidants
isocaloric, isonitrogenous
Outcomes
Primary Outcome Measures
compliance to nutrition therapy
Secondary Outcome Measures
anorexia questionnaire
gastrointestinal syndrome score (GIS)
body cell mass
weight change
hand grip strength
ECOG performance status
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00851448
Brief Title
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fresenius Kabi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Oral nutritional supplement containing n-3 fatty acids, amino acids, antioxidants
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
isocaloric, isonitrogenous
Intervention Type
Dietary Supplement
Intervention Name(s)
oral nutritional supplement, food for special medical purposes
Intervention Description
2 servings of 200-300 ml per day, treatment period: 16 weeks
Primary Outcome Measure Information:
Title
compliance to nutrition therapy
Time Frame
baseline, months 1, 2, 3, 4
Secondary Outcome Measure Information:
Title
anorexia questionnaire
Time Frame
baseline, months 1, 2, 3, 4
Title
gastrointestinal syndrome score (GIS)
Time Frame
baseline, months 1, 2, 3, 4
Title
body cell mass
Time Frame
baseline, months 1, 2, 3, 4
Title
weight change
Time Frame
baseline, months 1, 2, 3, 4
Title
hand grip strength
Time Frame
baseline, months 1, 2, 3, 4
Title
ECOG performance status
Time Frame
baseline, months 1, 2, 3, 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filippo Rossi-Fanelli, Professor
Organizational Affiliation
La Sapienza Università, Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dipartimento di Medicina Clinica, La Sapienza Università, Rome
City
Rome
ZIP/Postal Code
I- 00185
Country
Italy
Facility Name
Indywidualna Specjalistyczna Praktyka lekarska
City
Ruda Slaska
ZIP/Postal Code
41-709
Country
Poland
Facility Name
Pulmonology Dept. of Miedzylesie Hospital
City
Warsaw
ZIP/Postal Code
PL-04-749
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients
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