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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21996573