Clinical trial · Interventional
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
NCT00851448CI-TRIAL-00004938terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oral nutritional supplement, food for special medical purposes | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Oral nutritional supplement containing n-3 fatty acids, amino acids, antioxidants
- interventionNames
- Dietary Supplement: oral nutritional supplement, food for special medical purposes
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- isocaloric, isonitrogenous
- interventionNames
- Dietary Supplement: oral nutritional supplement, food for special medical purposes
Primary outcomes (1)
- measure
- compliance to nutrition therapy
- timeFrame
- baseline, months 1, 2, 3, 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.