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

Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients. A Randomised, Double-blind, Controlled Pilot Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00851448

Enrollment

Registered

2009-02-26

Start date

2009-10-31

Completion date

2011-04-30

Last updated

2011-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cachexia, Cancer

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.

Interventions

DIETARY_SUPPLEMENToral nutritional supplement, food for special medical purposes

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
gastrointestinal syndrome score (GIS)	baseline, months 1, 2, 3, 4
body cell mass	baseline, months 1, 2, 3, 4
anorexia questionnaire	baseline, months 1, 2, 3, 4
hand grip strength	baseline, months 1, 2, 3, 4
ECOG performance status	baseline, months 1, 2, 3, 4
weight change	baseline, months 1, 2, 3, 4

Countries

Italy, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026