Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr James A McCaul
ORCID ID
Contact details
Bradford Teaching Hospitals NHS Foundation Trust
St Lukes Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
jim.mccaul@btinternet.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
McCaul 01/2007
Study information
Scientific title
A multi-centre, randomised controlled trial assessing the effectiveness of Lugol's Iodine to assist excision of moderate dysplasia, severe dysplasia and carcinoma in situ at mucosal resection margin of oral and oropharyngeal squamous cell carcinoma.
Acronym
LIHNCS
Study hypothesis
Lugol's iodine demonstrates dysplastic cells at the margins of oral cavity and oropharynx Squamous Cell Carcinoma (SCCa). Data from our pilot study have suggested that using this technique allows surgeons resecting these tumours to identify and remove dysplastic tissue at the time of cancer resection. Using Lugol's stain reduced dysplasia at tumour margins from 32% to 2.7%; p=0.001 (95% CI 15.35 - 43.24). This should reduce local recurrence rates for this cancer type and site.
As of 10/12/2010, this record has been updated as funding has been secured to now roll this out as a larger multicentre trial. All updates to this record can be found in the relevant sections under the above update date. At this time, the anticipated start and end dates of the pilot study were extended to incorporate the main study; the initial details of the pilot study are as follows:
Initial anticipated start date: 01/03/2007
Initial anticipated end date: 01/06/2008
Please also note that the previous target number of participants for the pilot study was 164 participants, a further 300 will then be recruited for the main study.
As of 20/01/2011, the scientific title for this trial has been updated. The previous title was: "A prospective, multi-centre, randomised controlled trial looking at the effectiveness of Lugols Iodine to assist excision of marginal dysplasia at resection of oral and oropharyngeal squamous cell carcinoma".
Ethics approval
1. Pilot study approval: Northern and York Multicentre Research Ethics Committee (MREC) on 09/02/2007
2. Main study approval: Leeds (East) Research Ethics Committee on 26/08/2010 (ref: 10/H1306/29)
Study design
Randomised controlled blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Squamous cell carcinoma of the oral cavity and oropharynx
Intervention
Application of a mucolytic agent and then 1.25% iodine prior to surgery. Control group uses no stain.
Intervention type
Drug
Phase
Not Applicable
Drug names
Lugols Iodine
Primary outcome measure
Current information as of 10/12/2010:
Rates of surface dysplasia, carcinoma-in-situ or carcinoma at surface mucosal margins in the Lugols treated group versus gold standard management. Subgroup analysis of T1 and T2 versus T3 and T4 primary tumours.
Initial information at time of registration:
Incidence of moderate to severe dysplasia or carcinoma in situ at resection margins, assessed immediately after resection.
Secondary outcome measures
Current information as of 10/12/2010:
1. Acceptability of the technique to surgeons carrying our surgery for oral cavity and oropharynx cancer
2. Effect of Lugols technique on any further treatment carried out (radiotherapy or further surgery)
3. Estimate of the two year locoregional recurrence rates in each group
4. Mean and range of volume of tissue removed by each method
Initial information at time of registration:
Five year local recurrence rates.
Overall trial start date
01/11/2010
Overall trial end date
31/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current information as of 10/12/2010:
1. Written informed consent obtained
2. Patient is at least 18 years old
3. Histological diagnosis of squamous cell carcinoma
4. Oral or oropharyngeal primary
5. Patient for surgical resection of primary tumour
Initial information at time of registration:
Patients with squamous cell carcinoma of the oral cavity or oropharynx, undergoing primary surgery.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
Current information as of 10/12/2010:
1. Previous surgery, chemotherapy or radiotherapy for head and neck cancer
2. Known allergy to iodine
3. Distant metastases (positive neck nodes are not an exclusion)
4. Nasal, nasopharyngeal or occult primary carcinoma
5. Previous diagnosis of cancer in the past 5 years (except basal cell carcinoma or carcinoma of the cervix in situ)
Initial information at time of registration:
1. Previous surgery or radiotherapy for head and neck cancer
2. Documented allergy to iodine containing preparations
Recruitment start date
01/11/2010
Recruitment end date
31/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bradford Teaching Hospitals NHS Foundation Trust
Bradford
BD5 0NA
United Kingdom
Sponsor information
Organisation
Bradford Teaching Hospital NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD5 0NA
United Kingdom
john.wright@bradfordhospitals.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Local Trust Research Funds
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bradford Teaching Hospitals
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Leeds Teaching Hospitals
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Southern General Hospital Glasgow
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added 10/12/2010:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24063578
Publication citations
-
Protocol
McCaul JA, Cymerman JA, Hislop S, McConkey C, McMahon J, Mehanna H, Shaw R, Sutton DN, Dunn J, LIHNCS - Lugol's iodine in head and neck cancer surgery: a multicentre, randomised controlled trial assessing the effectiveness of Lugol's iodine to assist excision of moderate dysplasia, severe dysplasia and carcinoma in situ at mucosal resection margins of oral and oropharyngeal squamous cell carcinoma: study protocol for a randomised controlled trial., Trials, 2013, 14, 310, doi: 10.1186/1745-6215-14-310.