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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25291
Enrollment
40
Registered
2009-08-26
Start date
2009-02-09
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer patients

Interventions

1. Intake of study product
2. Duration of intervention: 8 days
3. Intervention group: cancer patients.

Sponsors

Danone Research ¨C Centre for Specialised Nutrition
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 ¡Ý 18 years; 5. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. 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 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).

Design outcomes

Primary

MeasureTime frame
1. 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

MeasureTime frame
Effects of nutritional supplementation on inflammatory status.

Contacts

Public ContactW. Graaf de

ziekenhuisapotheek MCA, Postbus 501

w.de.graaf@mca.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)