Cancer patients receiving RadioTherapy
Conditions
Interventions
Intake 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.
Sponsors
Danone Research ¨C Centre for Specialised Nutrition
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 criteria
Exclusion criteria: 1. 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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 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
| Measure | Time frame |
|---|---|
| Serum cytokine and C-reactive protein (CRP) levels. | — |
Contacts
Public ContactW. Graaf, de
Danone Research Bosrandweg 20
Outcome results
None listed