Safety, Tolerance and Efficacy of an Oral Nutritional Sup... | NCT00851448

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

NCT00851448

Sponsor

Fresenius Kabi

Status

Terminated

Last Update Posted

Jun 2, 2011Estimated

Enrollment

17Actual

Phase

Not Applicable

Conditions

Cachexia
Cancer

Interventions

oral nutritional supplement, food for special medical purposes

Countries

Italy
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Feb 13, 2009

First Submission Date that Met QC Criteria

Feb 25, 2009

First Posted Date

Feb 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2011

Last Update Posted Date

Jun 2, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
oral nutritional supplement, food for special medical purposes	Dietary Supplement	2 servings of 200-300 ml per day, treatment period: 16 weeks	1 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
anorexia questionnaire		baseline, months 1, 2, 3, 4
gastrointestinal syndrome score (GIS)		baseline, months 1, 2, 3, 4
body cell mass

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Filippo Rossi-Fanelli, Professor	La Sapienza Università, Rome	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dipartimento di Medicina Clinica, La Sapienza Università, Rome		Rome		I- 00185	Italy
Indywidualna Specjalistyczna Praktyka lekarska

Condition Browse Module

MeSH Terms

ID	Term
D002100	Cachexia
D009369	Neoplasms

Ancestor Terms

ID	Term
D015431	Weight Loss
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019587	Dietary Supplements
D005502	Food

Ancestor Terms

ID	Term
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided