LiTEFORM Light Therapy Effectiveness For Oral Mucositis
Research type
Research Study
Full 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.
IRAS ID
209809
Contact name
Michael Nugent
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 8 months, 4 days
Research summary
There are around 4000 people every year in England and Wales who are given chemotherapy or radiotherapy for their head and neck cancer. Most of these people will get a condition called oral mucositis as a side effect of their therapy. Patients with oral mucositis are likely to find that their ability to talk, eat and drink is affected and find it difficult to swallow. They can get painful swelling and ulcers in their mouth and on their tongue and lips.
The treatment for oral mucositis is not the same at every hospital but usually includes helping the patient keep their mouth and teeth clean, having a healthy balanced diet and drinking enough fluid. Patients can be given drugs to help with pain as well as special mouthwashes and coating gels. We call this the ‘standard treatment’.
There is a new treatment called Low Level Laser Therapy. This involves shining a weak laser light on the lining of the mouth. Early studies have shown that it may take down swelling, reduce pain and help healing. LiTEFORM will tell us how good the laser light is at cutting down pain and swelling during head and neck cancer treatment. It will also measure any impact on the quality of life for patients.
All patients will have the standard treatment at their hospital, and half the patients taking part in LiTEFORM will also be given laser therapy. Patients in group 1 will get the active laser therapy. Patients in group 2 will get the inactive therapy or ‘sham’ therapy, where the machine will not actually shine any light into the mouth. Patients will be randomly allocated to Group 1 or Group 2, with an equal chance of being in either group. The patient, machine operator and LiTEFORM team will not know which group the patient is in.
• Patients will be asked to complete some questionnaires once a week for six weeks, and again at their 4 months and 14 months head and neck follow up appointment.
• They will be asked to drink 100 millilitres of water as quickly as possible, on four occasions (before radiotherapy, on finishing radiotherapy, three and twelve months afterwards).
• They will be given up to three laser therapy sessions every week for six weeks. This will be done before their planned radiotherapy treatment.A sample of patients who have consented or declined the main trial will be invited to take part in a telephone interview. This is to find out about patient views and experiences of LiTEFORM and laser therapy if applicable. The initial consent discussion will be audio-recorded and then transcribed (written out). Staff involved in delivering LiTEFORM will be invited to interview (telephone/face to face) and some may also be observed during training sessions.
Up to 10 centres across England, Scotland and Wales will take part and use the laser therapy machine for this trial.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0096
Date of REC Opinion
28 Apr 2017
REC opinion
Further Information Favourable Opinion