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

ISRCTN	ISRCTN80845477
DOI	https://doi.org/10.1186/ISRCTN80845477
Protocol serial number	NTR264
Sponsor	Vrije University Medical Centre (VUMC) (Netherlands)
Funder	Abbott Laboratories (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr B. van der Meij
Scientific

P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Email	b.vandermeij@vumc.nl

Primary study design	Interventional
Study design	Randomised double blind placebo-controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	longdrinkstudy
Study objectives	A nutritional supplement enriched with omega-3 fatty acids has beneficial effects on functional and nutritional parameters and on quality of life (QOL) in non-small cell lung cancer (NSCLC) patients undergoing chemo(radiation)therapy and lung resection, compared to a control energy-dense nutritional supplement without omega-3 fatty acids.
Ethics approval(s)	Received from the local medical ethics committees
Health condition(s) or problem(s) studied	Non-small cell lung cancer (NSCLC)
Intervention	Group A (n = 20) will receive two packages per day of a nutritional supplement with 2 g eicosapentaenoic acid (EPA). Group B (n = 20) will receive two packages per day of a control nutritional supplement. Total duration of treatment = 8 weeks.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Omega-3 fatty acids
Primary outcome measure(s)	1. Muscle strength 2. Immune status 3. Nutritional status 4. Cancer cachexia
Key secondary outcome measure(s)	1. Quality of life (QOL) 2. Physical activity level (PAL) 3. Post-operative complications and survival
Completion date	01/09/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Aged 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
Key exclusion criteria	1. 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, human immunodeficiency virus [HIV])
Date of first enrolment	01/03/2005
Date of final enrolment	01/09/2006

P.O. Box 7057

Amsterdam
1007 MB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan