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TerminatedNCT00851448Updated Jun 2, 2011

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

An interventional study of oral nutritional supplement, food for special medical purposes in Cachexia and Cancer, sponsored by Fresenius Kabi. Terminated at 3 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-06-02.

Sponsored by Fresenius Kabi · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cachexia
  • Cancer

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03

In context

Cachexia

328 studies on the registry are indexed under Cachexia; 73 are open to participants now.

This study's enrollment of 17 is below the median of 63 across 219 interventional studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

Fresenius Kabi is the lead sponsor of 51 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    1

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

    Dietary Supplement: oral nutritional supplement, food for special medical purposes

  • Placebo comparator
    2

    isocaloric, isonitrogenous

    Dietary Supplement: oral nutritional supplement, food for special medical purposes

Interventions

  • Dietary supplementoral nutritional supplement, food for special medical purposes

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

06

What researchers measure

Primary outcomes

  1. compliance to nutrition therapy

    Time frame: baseline, months 1, 2, 3, 4

Secondary outcomes

  1. anorexia questionnaire

    Time frame: baseline, months 1, 2, 3, 4

  2. gastrointestinal syndrome score (GIS)

    Time frame: baseline, months 1, 2, 3, 4

  3. body cell mass

    Time frame: baseline, months 1, 2, 3, 4

  4. weight change

    Time frame: baseline, months 1, 2, 3, 4

  5. hand grip strength

    Time frame: baseline, months 1, 2, 3, 4

  6. ECOG performance status

    Time frame: baseline, months 1, 2, 3, 4

07

Study locations

3 sites
  • Dipartimento di Medicina Clinica, La Sapienza Università, Rome
    Rome, I- 00185, Italy
  • Indywidualna Specjalistyczna Praktyka lekarska
    Ruda Slaska, 41-709, Poland
  • Pulmonology Dept. of Miedzylesie Hospital
    Warsaw, PL-04-749, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00851448
Lead sponsor
Fresenius Kabi
First posted
Feb 26, 2009
Start date
Oct 2009
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Jun 2, 2011

Study contacts

Filippo Rossi-Fanelli, Professor
principal investigator · La Sapienza Università, Rome
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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