Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.vumc.nl

Funders

Funder type

Industry

Funder name

Abbott Laboratories (Netherlands)

Alternative name(s)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes