Oesophageal cancer Cancer Malignant neoplasm of oesophagus
Conditions
Interventions
Duration of intervention: 4 weeks pre-treatment
Active products: Nutritionally complete oral supplement, high in protein and leucine and enriched with fish oil, specific oligosaccharides and a balan
Sponsors
Danone Research (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. Newly diagnosed with carcinoma of the oesophagus or gastro-oesophageal junction (Siewert-Stein classification type I - III) 2. Age more than or equal to 18 years 3. Written informed consent Reference group (were included for baseline comparisons, no intervention in these subjects): 1. Age and sex-matched with the Dutch oesophagus cancer population 2. Written informed consent 3. Body mass index (BMI) 18.5-30 kg/m2
Exclusion criteria
Exclusion criteria: Patients: 1. Life expectancy 2 4. Any oesophagus related surgery after diagnosis before inclusion 5. Chemo- and/or radiotherapy in the past 5 years 6. 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, or corticosteroids (unless not considered to be systemically available)] 7. Dysphagia score of 4 using the dysphagia scoring system 8. Dependence on tube feed or parenteral nutrition in the last 4 weeks 9. Use of fish oil containing supplements during the last 4 weeks 10. Intolerance or allergy to dairy, fish, or other ingredients of the study products 11. Dependency on fibre free diet 12. If pre-menopausal female: pregnant or lactating 13. Dementia or altered mental status that would prohibit the understanding and giving of informed consent 14. Any other medical condition that may interfere with the safety of the patient or the outcome parameters, in the investigator?s judgment. 15. Investigator?s uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. alcohol abuse) Reference group (were included for baseline comparisons, no intervention in these subjects): 1. Significant involuntary weight loss in the past year 2. Smoking (defined as currently smoking or quit less than or equal to 6 months ago) 3. Acute or chronic disease 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, or corticosteroids (unless not considered to be systemically available)] 5. If pre-menopausal female: pregnant or lactating 6. Any other condition that may interfere with the definition ?healthy volunteer? according to the investigator?s judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effects of the Active sip feed on pre-treatment immune function in patients with newly diagnosed cancer of the oesophagus and to compare this with the effects of routine nutritional support. Immune function was measured by the ex vivo production of Th1/Th2 cytokines in ConA stimulated peripheral blood mononuclear cells (PBMC) and production of inflammatory cytokines and prostaglandin E2 (PGE2) in lipopolysaccharides (LPS)-stimulated PBMC, both at visit 1 and visit 3. Cytokines were measured by Bio-Plex assay and PGE2 by enzyme immunoassay (EIA). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the effects of the Active sip feed on pre-treatment nutritional status in patients with newly diagnosed cancer of the oesophagus and to compare this with the effects of routine nutritional support. 2. To obtain exploratory information on immune function and nutritional status post-surgery 3. To obtain data on immune and nutritional parameters in healthy volunteers to allow for adequate interpretation of the data from patients | — |
Countries
Netherlands
Outcome results
None listed