Plain English Summary
Lay summary under review with external organisation
Trial website
Contact information
Type
Public
Primary contact
Mrs Jenn Bingham
ORCID ID
Contact details
Newcastle Clinical Trials Unit
Newcastle University
1-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
+44 191 208 2520
jenn.bingham@newcastle.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
33975
Study information
Scientific title
A randomised controlled trial of the clinical and cost effectiveness of low level laser in the management of oral mucositis in head and neck cancer irradiation
Acronym
LiTEFORM
Study hypothesis
The aim of this study is to establish the benefit of Low Level Laser Therapy delivered 3 times weekly delivered by trained staff in the management of oral mucositis in head and neck cancer irradiation.
Ethics approval
West Midlands - Solihull Research Ethics Committee, 23/03/2017, ref: 17/WM/0096
Study design
Randomised; Interventional; Design type: Treatment, Prevention, Device
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Cancer, Primary sub-specialty: Head and Neck Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of lip, oral cavity and pharynx
Intervention
Patients will be randomised to one of two groups using a method of random permuted blocks of concealed variable block size and stratified by planned treatment (radiotherapy alone or chemo-radiotherapy), and unilateral or bilateral radiotherapy fields. To ensure concealment of allocation, patients will be centrally randomised by the Newcastle Clinical Trials Unit using a secure web-based system.
Intervention group: Participants receive LLLT plus standard care 3 times weekly by a non-contact method for a period of 6 weeks (from day 1 of radiotherapy dose).
Control group: Participants receive sham LLLT plus standard care 3 times weekly by a non-contact method for a period of 6 weeks (from day 1 of radiotherapy dose).
The LLLT will be a red laser, wavelength 660nm, power output 75mW beam area 1.5cm2, irradiance 50mW/cm2, exposure time 60 seconds, fluence 3J/cm2 per spot. LLLT will be administered within 60 minutes before the radiotherapy session, with a minimum of 24 hours between each of the 3 laser therapy sessions. Each session will last 20-30 minutes, with LLLT at 6 pre-determined anatomical sites in the oral cavity.
All patients will also receive the standard care offered for oral mucositis by each centre. Standard care varies across NHS Trusts but typically consists of oral hygiene instruction, topical analgesics and coating gels.
Follow ups will be done at the week 12, month 4 and month 14 standard care head and neck visits.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Clinical effectiveness and cost effectiveness of LLLT plus standard care vs standard care alone is measured by comparing the OMWQ-HN score at 6 weeks following the start of radiotherapy (+/- 2 weeks) in the two randomised arms.
Secondary outcome measures
1. Effectiveness of LLLT in preventing severe oral mucositis during radiotherapy for head and neck cancer is measured using OMWQ-HN and WHO mucositis at baseline and weekly during 1 to 6 of LLLT
2. Long term reported health related quality of life as measured by EORTC QLQ C30 (version 3.0), EORTC QLQ C30/H&N 35 (EORTC QOL Module for Head and Neck Cancer) and the EQ-5D-5L at baseline, week 6, month 4 and month 14, and MDADI at baseline, week 6, month 4 and month 14
3. Nutritional Parameters as measured by Performance Status Scale’s (PSS-HN) collected weekly at baseline, weeks 1-6, month 4 and month 14. Recording of weekly weight changes from baseline during treatment, the quantity of enteral nutrition consumed, number of days of feeding tube in situ
4. Changes in swallowing function measured by the timed water swallow test collected at baseline, week 6 of LLLT month 4 and month 14
5. Pain outcomes as measured by use of analgesics/ topical treatment and pain domain of EQ-5D-5L and OMWQ-HN at randomisation and weekly to week 6 during treatment
6. Safety, specifically adverse events attributed to LLLT and clinical complications notably number of days as inpatient hospital admissions and interruptions in CRT treatment (recorded weekly 1-6 during treatment)
7. Clinical outcomes specifically patient survival, quality-adjusted survival recurrence and persistence of disease at 14 months
Economic outcomes:
1. Incremental cost per change in OMWQ-HN score recorded between baseline and at week 6 of therapy and incremental cost per QALY over 14 months
2. Quality-adjusted life years based upon EQ-5D-5L and EORTC-8D utility scores measured at baseline, week 6 and 4 and 14 months
3. Costs associated with treatment (weeks 0-6) will be collected weekly via the eCRFs (e.g. adverse events and use of analgesics)
4. Health care utilisation based on responses to Health Utilisation Questionnaire administered at 4 and 14 months (assessing: visits to the GP/walk-in clinic/A&E etc.)
5. Participant and family costs collected via the Time and Travel Questionnaire administered at 14 months
6. Total costs of LLLT and sham LLLT measured at 4 and 14 months, from the perspective of the NHS and personal and social services to participants and families
Qualitative outcomes as identified through measurement of:
1. Observations of site initiation visits and device training conducted prior to the opening of each site
2. Interviews with health professionals delivering LLLT conducted and other relevant members of head and neck cancer team throughout the trial using purposeful sampling, with no more than 2 interviews per staff member
3. Interviews with patients, at 1-2 weeks after the recruitment discussion, and at approximately month 4 or month 14. There will be no more than 2 interviews per patient
Overall trial start date
01/11/2016
Overall trial end date
31/12/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults aged ≥ 18 years diagnosed with HNC
2. Capacity to provide informed written consent
3. Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, larynx, hypopharynx or unknown squamous cell primary of head and neck origin histologically confirmed
4. (C)RT patients discussed in a Head and Neck MDT meeting and deemed medically fit for an agreed treatment plan for primary or adjuvant radiotherapy ± concurrent or induction chemotherapy (cisplatin or cetuximab)
5. Patients planned to receive a minimum of 60Gy to a defined clinical target volume in the oral cavity or oropharynx, or neck levels Ia/b as defined by the current RTOG criteria
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 380; UK Sample Size: 380
Participant exclusion criteria
1. Known to be pregnant or planning to become pregnant within the trial treatment period
2. Parotid tumours
3. Previous radiotherapy for HNC
4. Current/ongoing OM and trismus limiting laser access for treatment
5. Patients who are experiencing active heavy tumour bleeding from the mouth (haemorrhage)
6. Patients for whom the MDT recommend short course palliative radiotherapy
7. Patients on immune suppressant drugs (except low dose steroids)
8. Participation in other trials assessing different treatments for OM
9. Unable to provide written informed consent
Recruitment start date
28/04/2017
Recruitment end date
30/04/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Velindre Cancer Centre
Velindre Road
Whitchurch
Cardiff
CF14 2TL
United Kingdom
Trial participating centre
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Trial participating centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Trial participating centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Sponsor details
Freeman Hospital
Freeman Road
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom
+44 191 2825789
Aaron.Jackson@nuth.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The findings from this trial will be disseminated to the relevant stakeholders, including medical professionals involved in the Clinical Commissioning Groups, specialised service providers, cancer research institutes, Clinical Review Groups and patient organisations. Findings will also be published in peer reviewed journals, including open access publications, as well as conferences. The domain name www.liteform.org.uk will be used to retain stakeholder engagement as well as publicising the results. Findings from the qualitative sub study will be fed into the trial, as well as published in selected qualitative papers at the end of the trial.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2020
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary