Contact information
Type
Scientific
Primary contact
Dr B. van der Meij
ORCID ID
Contact details
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
b.vandermeij@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR264
Study information
Scientific title
Acronym
longdrinkstudy
Study hypothesis
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
Received from the local medical ethics committees
Study design
Randomised double blind placebo-controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Omega-3 fatty acids
Primary outcome measure
1. Muscle strength
2. Immune status
3. Nutritional status
4. Cancer cachexia
Secondary outcome measures
1. Quality of life (QOL)
2. Physical activity level (PAL)
3. Post-operative complications and survival
Overall trial start date
01/03/2005
Overall trial end date
01/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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])
Recruitment start date
01/03/2005
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Abbott Laboratories (Netherlands)
Alternative name(s)
Abbott
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list