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


- candidate number6759
- NTR NumberNTR2121
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2009
- Secondary IDsonc.2.c/h Danone Research
- Public TitleEPA Incorporation and Immune responses after nutritional supplementation in Cancer patients receiving RadioTherapy.
- Scientific TitleEPA Incorporation and Immune responses after nutritional supplementation in Cancer patients receiving RadioTherapy.
- ACRONYMEIIC-RT
- hypothesisIt is expected that 8 days 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, Radiotherapy
- Inclusion criteria1. Pathologically confirmed solid tumor(s);
2. Receiving radiotherapy during the study;
3. Body Mass Index 18.5 ¨C 30 kg/ m2;
4. Willing and able to abstain from use of alcohol, smoking, fish (fatty fish e.g. salmon, mackerel, herring, eel), fish oil containing supplements, vitamin supplements, herbal supplements or oil supplements (e.g. evening primrose oil);
5. Age ¡Ý 18 years;
6. Written informed consent.
- Exclusion criteria1. Surgery and / or chemotherapy within the past 6 weeks;
2. Previous radiotherapy ( before current treatment cycles ) within the past 6 weeks;
3. Use of supplements containing fish oil, herbal or oil supplements (e.g. evening primrose oil) during the previous 4 weeks;
4. Intolerance or allergy to dairy products, fish, or other ingredients of the study products;
5. 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)). See Appendix I for the immune modification medication list;
6. Currently smoking and smoking in the past 6 months;
7. Life expectancy < 3 months;
8. ECOG performance status > 2;
9. Dependence on tube feed or parenteral nutrition in the last 4 weeks;
10. If pre-menopausal female: pregnant or lactating;
11. Dementia or altered mental status that would prohibit the understanding and giving of informed consent;
12. Any other medical condition that may interfere with the safety of the patient or the outcome parameters, in the investigator¡¯s judgment;
13. 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 trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-dec-2009
- planned closingdate31-dec-2009
- Target number of participants40
- InterventionsIntake of study product; duration of intervention: 8 days.
Intervention group: cancer patients receiving radiotherapy.
An Active sip feed will be compared with a Routine sip feed.
- Primary outcome1. Percentage EPA and DHA of total phospholipid fatty acids of cell membranes of white and red blood cells and plasma;
2. Ex vivo pro-inflammatory cytokine and prostaglandin E2 (PGE2) production in lipopolysaccharide (LPS)-stimulated whole blood.
- Secondary outcomeSerum cytokine and C-reactive protein (CRP) levels.
- TimepointsDay 1 and day 8.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES W. Graaf, de
- CONTACT for SCIENTIFIC QUERIES Mirian Lansink
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryIn this trial an Active sip feed will be compared with a Routine sip feed in cancer patients receiving radiotherapy. The study product will be used for eight days. Blood samples will be collected at day 1 and 8.
- Main changes (audit trail)
- RECORD2-dec-2009 - 5-apr-2010


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