tritional Support in Patients with newly diagnosed oEsophageal Cancer

Completed

• Conditions: Oesophageal cancer; Cancer; Malignant neoplasm of oesophagus

• Registration Number: ISRCTN28490479
• Lead Sponsor: Danone Research (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 67

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

Patients:
1. Life expectancy < 3 months
2. Planned start of cancer treatment within 3 weeks
3. Eastern Cooperative Oncology Group (ECOG) performance status > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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 Outcome Measures

Name	Time	Method
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.<br>2. To obtain exploratory information on immune function and nutritional status post-surgery<br>3. To obtain data on immune and nutritional parameters in healthy volunteers to allow for adequate interpretation of the data from patients