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Effects of enteral nutrition enriched with omega-3 fatty acids on outcome in non-small cell lung cancer patients.


- candidate number1457
- NTR NumberNTR264
- ISRCTNISRCTN80845477
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR8-sep-2005
- Secondary IDsN/A 
- Public TitleEffects of enteral nutrition enriched with omega-3 fatty acids on outcome in non-small cell lung cancer patients.
- Scientific TitleEffects of enteral nutrition enriched with omega-3 fatty acids on outcome in non-small cell lung cancer patients.
- ACRONYMlongdrinkstudy
- hypothesisA nutritional supplement enriched with omega-3 fatty acids has beneficial effects on functional and nutritional parameters and on quality of life (QOL) in NSCLC patients undergoing chemo(radiation)therapy and lung resection, compared to a control energy-dense nutritional supplement without omega-3 fatty acids.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC)
- Inclusion criteria1. Age 18 to 75 years;
2. Diagnosis NSCLC stage III;
3. Resolved treatment plan: neo-adjuvant chemo(radiation)therapy during 6 weeks and, dependent on disease regression, tumour resection;
4. Life expectancy greater than 3 months;
5. Written informed consent.
- Exclusion criteria1. Surgery, chemo- or radiation therapy during the previous month;
2. Oedema or ascites;
3. Use of fish oil supplements during the last month;
4. Use of high dose corticosteroids (low dose, inhalation steroids and/or local use is permitted);
5. Other active medical conditions (major gastrointestinal disease, chronic renal failure, uncontrolled diabetes mellitus, HIV).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2005
- planned closingdate1-sep-2007
- Target number of participants40
- InterventionsGroup A (n=20) will receive 2 packages per day of a nutritional supplement with 2 g EPA. Group B(n=20) will receive 2 packages per day of a control nutritional supplement.
- Primary outcome1. Muscle strength;
2. Immune status;
3. Nutritional status;
4. Cancer cachexia.
- Secondary outcome1. Quality of life (QOL);
2. Physical activity level (PAL);
3. Post-operative complications and survival.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES B. Meij, van der
- CONTACT for SCIENTIFIC QUERIES B. Meij, van der
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Abbott Laboratories
- PublicationsN/A
- Brief summaryA single centre, double blind placebo controlled trial on the effects of EPA on muscle strength, immune status, nutritional status and cancer cachexia in 40 NSCLC patients receiving chemo(radiation) therapy. Patients will receive either an EPA-enriched nutritional supplement or a control nutritional supplement for at least 8 weeks.
- Main changes (audit trail)
- RECORD13-sep-2005 - 5-jan-2010


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