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
Secondary identifying numbers NTR264
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
13/05/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
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

Contact information

Dr B. van der Meij
Scientific

P.O. Box 7057
Amsterdam
1007 MB
Netherlands

b.vandermeij@vumc.nl

Study information

Study designRandomised double blind placebo-controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymlongdrinkstudy
Study objectivesA 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) studiedNon-small cell lung cancer (NSCLC)
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Omega-3 fatty acids
Primary outcome measure1. Muscle strength
2. Immune status
3. Nutritional status
4. Cancer cachexia
Secondary outcome measures1. Quality of life (QOL)
2. Physical activity level (PAL)
3. Post-operative complications and survival
Overall study start date01/03/2005
Completion date01/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteria1. 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 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, human immunodeficiency virus [HIV])
Date of first enrolment01/03/2005
Date of final enrolment01/09/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (Netherlands)
University/education

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

http://www.vumc.nl
ROR logo https://ror.org/00q6h8f30

Funders

Funder type

Industry

Abbott Laboratories (Netherlands)
Government organisation / For-profit companies (industry)
Alternative name(s)
Abbott, Abbott U.S., Abbott Alkaloidal Company
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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