Condition category
Cancer
Date applied
09/01/2007
Date assigned
09/10/2007
Last edited
23/10/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 Lugol’s 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

Lugol’s Iodine

Primary outcome measures

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.

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 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.

Overall trial start date

01/11/2010

Overall trial end date

31/10/2014

Reason abandoned

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

http://www.bradfordhospitals.nhs.uk/

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24063578

Publication citations

  1. 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.

Additional files

Editorial Notes