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Clinical Trials/ISRCTN28490479
ISRCTN28490479
Completed
Not Applicable

tritional Support in Patients with newly diagnosed oEsophageal Cancer: a randomised, double blind, controlled clinical trial

Danone Research (Netherlands)0 sites67 target enrollmentJune 10, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Danone Research (Netherlands)
Enrollment
67
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 10, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Danone Research (Netherlands)

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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

Outcomes

Primary Outcomes

Not specified

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