Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0055143763
Study information
Scientific 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.
Acronym
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?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Gastrointestinal
Intervention
Patients, after obtaining informed consent, are randomly assigned one of the nutritional supplements, both of similar calorific value but one contains EPA.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Measurements of QoL, weight etc. are made at monthly interval, follow-up until death.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2002
Overall trial end date
30/06/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with histologically diagnosed oesophageal or proximal gastric cancer that are not receiving curative treatment.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2002
Recruitment end date
30/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Cumbria Acute Hospitals NHS Trust
Carlisle
CA2 7HY
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Cumbria Acute Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list