|
ISRCTN
|
ISRCTN94245249
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Pilot study on the effects of oral immuno-nutrition on the quality of life in patients receiving palliative treatment for oesophageal and proximal gastric cancer.
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0055143763
|
|
Study hypothesis
|
Does EPA supplementation affect patients' quality of life and survival with known esophageal and proximal gastric cancer who are receiving non-curative treatments?
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cancer: Gastrointestinal
|
|
Participants - inclusion criteria
|
Patients with histologically diagnosed oesophageal or proximal gastric cancer that are not receiving curative treatment.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/06/2002
|
|
Anticipated end date
|
30/06/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Patients, after obtaining informed consent, are randomly assigned one of the nutritional supplements, both of similar calorific value but one contains EPA.
|
|
Primary outcome measure(s)
|
Measurements of QoL, weight etc. are made at monthly interval, follow-up until death.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
North Cumbria Acute Hospitals NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
Martin
White
|
|
Address
|
North Cumbria Acute Hospitals NHS Trust
Cumberland Infirmary
|
|
City/town
|
Carlisle
|
|
Zip/Postcode
|
CA2 7HY
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2005
|
|
Last edited
|
21/04/2011
|
|
Date ISRCTN assigned
|
30/09/2005
|