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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cachexia Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

oral nutritional supplement, food for special medical purposes

Intervention Type DIETARY_SUPPLEMENT

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

2

isocaloric, isonitrogenous

Group Type PLACEBO_COMPARATOR

oral nutritional supplement, food for special medical purposes

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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oral nutritional supplement, food for special medical purposes

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No