No registrations found.
ID
Source
Brief title
Health condition
NSCLC
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Muscle strength;
2. Immune status;
3. Nutritional status;
4. Cancer cachexia.
Secondary outcome
1. Quality of life (QOL);
2. Physical activity level (PAL);
3. Post-operative complications and survival.
Background summary
A 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.
Study objective
A 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.
Study design
N/A
Intervention
Group 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.
P.O. Box 7057
B. Meij, van der
Amsterdam 1007 MB
The Netherlands
b.vandermeij@vumc.nl
P.O. Box 7057
B. Meij, van der
Amsterdam 1007 MB
The Netherlands
b.vandermeij@vumc.nl
Inclusion criteria
1. 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 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, HIV).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL228 |
| NTR-old | NTR264 |
| Other | : N/A |
| ISRCTN | ISRCTN80845477 |