Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
22/05/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Terry Jones

ORCID ID

Contact details

Critical Care Unit
Anaesthesia Department
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
+44 (0)151 529 5248
t.m.jones@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025128396

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer: Head and neck

Intervention

To assess efficacy of immune enhancing feeds (Impact) compared with standard feeds in head and neck cancer patients with percutaneous endoscopic gastrostomy (PEG) / nasogastric (NG) tube

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2005

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Aged 18+

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

160 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2005

Recruitment end date

01/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Critical Care Unit
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Aintree 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

Results - basic reporting

Publication summary

1. Ghosh S, et al., A double blind, randomised, placebo controlled, feasibility phase III clinical trial of perioperative immune-enhancing enteral nutrition in patients undergoing surgery for advanced head and neck cancer, e-SPEN Journal (2012),
doi:10.1016/j.clnme.2011.12.001

Publication citations

Additional files

Editorial Notes