Lugol’s Iodine in Head and Neck Cancer Surgery

ISRCTN ISRCTN03712770
DOI https://doi.org/10.1186/ISRCTN03712770
Protocol serial number McCaul 01/2007
Sponsor Bradford Teaching Hospital NHS Foundation Trust (UK)
Funders Local Trust Research Funds, Bradford Teaching Hospitals, Leeds Teaching Hospitals, Southern General Hospital Glasgow, Added 10/12/2010:, Cancer Research UK (CRUK) (UK)
Submission date
09/01/2007
Registration date
09/10/2007
Last edited
03/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-using-dye-during-surgery-for-mouth-and-throat-cancer-LIHNCS

Contact information

Dr James A McCaul
Scientific

Bradford Teaching Hospitals NHS Foundation Trust
St Lukes Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom

jim.mccaul@btinternet.com

Study information

Primary study designInterventional
Study designRandomised controlled blinded trial
Secondary study designRandomised controlled trial
Scientific titleA 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.
Study acronymLIHNCS
Study objectivesLugol'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 Lugol’s Iodine to assist excision of marginal dysplasia at resection of oral and oropharyngeal squamous cell carcinoma".
Ethics approval(s)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)
Health condition(s) or problem(s) studiedSquamous cell carcinoma of the oral cavity and oropharynx
InterventionApplication of a mucolytic agent and then 1.25% iodine prior to surgery. Control group uses no stain.
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Lugol’s Iodine
Primary outcome measure(s)

Current information as of 10/12/2010:
Rates of surface dysplasia, carcinoma-in-situ or carcinoma at surface mucosal margins in the Lugol’s 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.

Key secondary outcome measure(s)

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 Lugol’s 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.

Completion date31/10/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration300
Key inclusion criteriaCurrent 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.
Key exclusion criteriaCurrent 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
Date of first enrolment01/11/2010
Date of final enrolment31/10/2014

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Bradford Teaching Hospitals NHS Foundation Trust
Bradford
BD5 0NA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 24/09/2013 Yes No
Abstract results results abstract 20/05/2017 No No

Editorial Notes

03/10/2018: Publication reference added.

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