Lugols Iodine in Head and Neck Cancer Surgery
| ISRCTN | ISRCTN03712770 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03712770 |
| Secondary identifying numbers | McCaul 01/2007 |
- 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
Contact information
Dr James A McCaul
Scientific
Scientific
Bradford Teaching Hospitals NHS Foundation Trust
St Lukes Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom
| jim.mccaul@btinternet.com |
Study information
| Study design | Randomised controlled blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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. |
| Study 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(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) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/11/2010 |
| Overall study end date | 31/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| 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 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
- England
- United Kingdom
Study participating centre
Bradford Teaching Hospitals NHS Foundation Trust
Bradford
BD5 0NA
United Kingdom
BD5 0NA
United Kingdom
Sponsor information
Bradford Teaching Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD5 0NA
England
United Kingdom
| john.wright@bradfordhospitals.nhs.uk | |
| Website | http://www.bradfordhospitals.nhs.uk/ |
"ROR" |
https://ror.org/05gekvn04 |
Funders
Funder type
Charity
Local Trust Research Funds
No information available
Bradford Teaching Hospitals
No information available
Leeds Teaching Hospitals
No information available
Southern General Hospital Glasgow
No information available
Added 10/12/2010:
No information available
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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.
