Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively 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

Dr Stanley Parikh

ORCID ID

Contact details

AintreeTrust
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
+44 0151 529 5283
sparikh@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0025177121

Study information

Scientific title

A double blind RCT of selective supraomohyoid neck dissection with/without level 2b for node negative oral cancer and resulting shoulder function

Acronym

Study hypothesis

The aim of the project is to compare patient derived and clinician rated morbidity, in terms of shoulder function, following a selective 1-3 level neck dissection in two groups of patients randomised for inclusion of level 2b in the neck and shoulder.

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

This will be a pilot study for a double blind randomised controlled trial. 60 patients requiring selective 1-3 level neck dissection as part of their overall treatment plan would be randomised as to whether they have a level 2b or not.

Assessment will be at 3 points: baseline, six weeks post operatively and 6 months. There will be monitoring for 2 years using existing follow-up protocols for neck node recurrence. Assessment will include: neurophysiology examination, clinical examination, self-completed questionnaires.

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

01/01/2006

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with previously untreated oral cancer arising from the floor of the mouth and anterior two thirds of tongue who are neck node negative both clinically and on MRI scan.
2. Requiring selective 1-3 level neck dissection as part of their overall treatment plan.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2006

Recruitment end date

01/01/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

AintreeTrust
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

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

Funder name

NHS R&D Support Funding

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

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21996573

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.