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EPA Incorporation and Immune responses after nutritional supplementation in Cancer patients.


- candidate number6352
- NTR NumberNTR1966
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-aug-2009
- Secondary IDsNL27755.072.09 IRB Nijmegen
- Public TitleEPA Incorporation and Immune responses after nutritional supplementation in Cancer patients.
- Scientific TitleEPA Incorporation and Immune responses after nutritional supplementation in Cancer patients.
- ACRONYMEIIC
- hypothesisIt is expected that one week of supplementation with the study product will contribute to an improved immune response and to increased incorporation of EPA and DHA in white and red blood cells and plasma.
- Healt Condition(s) or Problem(s) studiedCancer
- Inclusion criteria1. Pathologically confirmed solid tumor(s);
2. Body Mass Index 18.5 - 30 kg/ m2;
3. Willing and able to abstain from use of alcohol, smoking, fish (fatty fish e.g. salmon, mackerel, herring, eel), fish oil containing supplements and vitamin supplements or oil supplements (e.g. evening primrose oil);
4. Age 18 years;
5. Written informed consent.
- Exclusion criteria1. Surgery, radiotherapy, chemotherapy and or hormone therapy less than 2 months ago or planned within the study period;
2. Use of supplements containing fish oil, vitamins or oil supplements (e.g. evening primrose oil) during the previous 4 weeks;
3. Intolerance or allergy to dairy products, fish, or other ingredients of the study products;
4. Altered immune function (e.g. caused by major active infection, autoimmune disease, active allergy, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, or by use of medication such as immunosuppressive drugs, immunomodulators including NSAIDs, or corticosteroids (unless not considered to be systemically available) as listed in appendix I);
5. Currently smoking and smoking in the past 6 months;
6. Life expectancy < 3 months;
7. ECOG performance status > 2;
8. Dependence on tube feed or parenteral nutrition in the last 4 weeks;
9. If pre-menopausal female: pregnant or lactating;
10. Dementia or altered mental status that would prohibit the understanding and giving of informed consent;
11. Any other medical condition that may interfere with the safety of the patient or the outcome parameters, in the investigator's judgement;
12. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. alcohol abuse).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-feb-2009
- planned closingdate31-okt-2009
- Target number of participants40
- Interventions1. Intake of study product;
2. Duration of intervention: 8 days;
3. Intervention group: cancer patients.
- Primary outcome1. Incorporation kinetics of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in membrane phospholipids of white and red blood cells and plasma phospholipids;
2. Effects on ex vivo immune responses in cancer patients.
- Secondary outcomeEffects of nutritional supplementation on inflammatory status.
- Timepoints8 days intervention; study visit at start and at end of intervention.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES W. Graaf de
- CONTACT for SCIENTIFIC QUERIES M. Berkhout
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryThe purpose of this study is to assess the effect of the study product (an energy dense protein rich oral supplement enriched with fish oil, fibre and leucine) on incorporation kinetics of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in membrane phospholipids of white and red blood cells and plasma phospholipids and to assess effects on ex vivo immune responses in cancer patients. It is expected that one week of supplementation with the study product will contribute to an improved immune response and to incorporation of EPA and DHA in white and red blood cells and plasma.
- Main changes (audit trail)
- RECORD26-aug-2009 - 21-sep-2010


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