Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT
Background: Oral mucositis is a debilitating and painful complication of head and neck cancer irradiation that is characterised by inflammation of the mucous membranes, erythema and ulceration. Oral mucositis affects 6000 head and neck cancer patients per year in England and Wales. Current treatment...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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NIHR Journals Library
2022-12-01
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| Series: | Health Technology Assessment |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/UWNB3375 |
| _version_ | 1811179302682624000 |
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| author | Michael Nugent Valerie Bryant Chrissie Butcher Holly Fisher Sean Gill Rebecca Goranova Shaun Hiu Lyndsay Lindley James O’Hara Yemi Oluboyede Joanne Patterson Tim Rapley Tomos Robinson Nikki Rousseau Vicky Ryan Ramkumar Shanmugasundaram Linda Sharp Ruby Smith Whelan Deborah D Stocken Laura Ternent Janet Wilson Jenn Walker |
| author_facet | Michael Nugent Valerie Bryant Chrissie Butcher Holly Fisher Sean Gill Rebecca Goranova Shaun Hiu Lyndsay Lindley James O’Hara Yemi Oluboyede Joanne Patterson Tim Rapley Tomos Robinson Nikki Rousseau Vicky Ryan Ramkumar Shanmugasundaram Linda Sharp Ruby Smith Whelan Deborah D Stocken Laura Ternent Janet Wilson Jenn Walker |
| author_sort | Michael Nugent |
| collection | DOAJ |
| description | Background: Oral mucositis is a debilitating and painful complication of head and neck cancer irradiation that is characterised by inflammation of the mucous membranes, erythema and ulceration. Oral mucositis affects 6000 head and neck cancer patients per year in England and Wales. Current treatments have not proven to be effective. International studies suggest that low-level laser therapy may be an effective treatment. Objectives: To assess the clinical effectiveness and cost-effectiveness of low-level laser therapy in the management of oral mucositis in head and neck cancer irradiation. To identify barriers to and facilitators of implementing low-level laser therapy in routine care. Design: Placebo-controlled, individually randomised, multicentre Phase III superiority trial, with an internal pilot and health economic and qualitative process evaluations. The participants, outcome assessors and therapists were blinded. Setting: Nine NHS head and neck cancer sites in England and Wales. Participants: A total of 87 out of 380 participants were recruited who were aged ≥ 18 years and were undergoing head and neck cancer irradiation with ≥ 60 Gy. Intervention: Random allocation (1 : 1 ratio) to either low-level laser therapy or sham low-level laser therapy three times per week for the duration of irradiation. The diode laser had the following specifications: wavelength 660 nm, power output 75 mW, beam area 1.5 cm2, irradiance 50 mW/cm2, exposure time 60 seconds and fluence 3 J/cm2. There were 20–30 spots per session. Sham low-level laser therapy was delivered in an identical manner. Main outcome measure: The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks following the start of irradiation. Higher scores indicate a worse outcome. Results: A total of 231 patients were screened and, of these, 87 were randomised (low-level laser therapy arm, n = 44; sham arm, n = 43). The mean age was 59.4 years (standard deviation 8.8 years) and 69 participants (79%) were male. The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks was 33.2 (standard deviation 10) in the low-level laser therapy arm and 27.4 (standard deviation 13.8) in the sham arm. Limitations: The trial lacked statistical power because it did not meet the recruitment target. Staff and patients willingly participated in the trial and worked hard to make the LiTEFORM trial succeed. However, the task of introducing, embedding and sustaining new low-level laser therapy services into a complex care pathway proved challenging. Sites could deliver low-level laser therapy to only a small number of patients at a time. The administration of low-level laser therapy was viewed as straightforward, but also time-consuming and sometimes uncomfortable for both patients and staff, particularly those staff who were not used to working in a patient’s mouth. Conclusions: This trial had a robust design but lacked power to be definitive. Low-level laser therapy is relatively inexpensive. In contrast with previous trials, some patients found low-level laser therapy sessions to be difficult. The duration of low-level laser therapy sessions is, therefore, an important consideration. Clinicians experienced in oral cavity work most readily adapt to delivering low-level laser therapy, although other allied health professionals can be trained. Blinding the clinicians delivering low-level laser therapy is feasible. There are important human resource, real estate and logistical considerations for those setting up low-level laser therapy services. Future work: Further well-designed randomised controlled trials investigating low-level laser therapy in head and neck cancer irradiation are needed, with similar powered recruitment targets but addressing the recruitment challenges and logistical findings from this research. Trial registration: This trial is registered as ISRCTN14224600. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 46. See the NIHR Journals Library website for further project information. |
| first_indexed | 2024-04-11T06:33:39Z |
| format | Article |
| id | doaj.art-47fd86ef2d614024b95d47849f06f0f7 |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-04-11T06:33:39Z |
| publishDate | 2022-12-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-47fd86ef2d614024b95d47849f06f0f72022-12-22T04:39:55ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242022-12-01264610.3310/UWNB337515/57/160Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCTMichael Nugent0Valerie Bryant1Chrissie Butcher2Holly Fisher3Sean Gill4Rebecca Goranova5Shaun Hiu6Lyndsay Lindley7James O’Hara8Yemi Oluboyede9Joanne Patterson10Tim Rapley11Tomos Robinson12Nikki Rousseau13Vicky Ryan14Ramkumar Shanmugasundaram15Linda Sharp16Ruby Smith Whelan17Deborah D Stocken18Laura Ternent19Janet Wilson20Jenn Walker21Department of Oral and Maxillofacial Surgery, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UKChange Head and Neck Cancer Research Patient Involvement Group, Sunderland, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKPlymouth Oncology Centre, University Hospitals Plymouth NHS Trust, Plymouth, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKSocial Policy Research Unit, University of York, York, UKEar, Nose and Throat Department, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKSchool of Health Sciences, University of Liverpool, Liverpool, UKDepartment of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKClinical Oncology, University Hospital Southampton NHS Foundation Trust, Southampton, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKLeeds Institute of Clinical Trials Research, University of Leeds, Leeds, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UKBackground: Oral mucositis is a debilitating and painful complication of head and neck cancer irradiation that is characterised by inflammation of the mucous membranes, erythema and ulceration. Oral mucositis affects 6000 head and neck cancer patients per year in England and Wales. Current treatments have not proven to be effective. International studies suggest that low-level laser therapy may be an effective treatment. Objectives: To assess the clinical effectiveness and cost-effectiveness of low-level laser therapy in the management of oral mucositis in head and neck cancer irradiation. To identify barriers to and facilitators of implementing low-level laser therapy in routine care. Design: Placebo-controlled, individually randomised, multicentre Phase III superiority trial, with an internal pilot and health economic and qualitative process evaluations. The participants, outcome assessors and therapists were blinded. Setting: Nine NHS head and neck cancer sites in England and Wales. Participants: A total of 87 out of 380 participants were recruited who were aged ≥ 18 years and were undergoing head and neck cancer irradiation with ≥ 60 Gy. Intervention: Random allocation (1 : 1 ratio) to either low-level laser therapy or sham low-level laser therapy three times per week for the duration of irradiation. The diode laser had the following specifications: wavelength 660 nm, power output 75 mW, beam area 1.5 cm2, irradiance 50 mW/cm2, exposure time 60 seconds and fluence 3 J/cm2. There were 20–30 spots per session. Sham low-level laser therapy was delivered in an identical manner. Main outcome measure: The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks following the start of irradiation. Higher scores indicate a worse outcome. Results: A total of 231 patients were screened and, of these, 87 were randomised (low-level laser therapy arm, n = 44; sham arm, n = 43). The mean age was 59.4 years (standard deviation 8.8 years) and 69 participants (79%) were male. The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks was 33.2 (standard deviation 10) in the low-level laser therapy arm and 27.4 (standard deviation 13.8) in the sham arm. Limitations: The trial lacked statistical power because it did not meet the recruitment target. Staff and patients willingly participated in the trial and worked hard to make the LiTEFORM trial succeed. However, the task of introducing, embedding and sustaining new low-level laser therapy services into a complex care pathway proved challenging. Sites could deliver low-level laser therapy to only a small number of patients at a time. The administration of low-level laser therapy was viewed as straightforward, but also time-consuming and sometimes uncomfortable for both patients and staff, particularly those staff who were not used to working in a patient’s mouth. Conclusions: This trial had a robust design but lacked power to be definitive. Low-level laser therapy is relatively inexpensive. In contrast with previous trials, some patients found low-level laser therapy sessions to be difficult. The duration of low-level laser therapy sessions is, therefore, an important consideration. Clinicians experienced in oral cavity work most readily adapt to delivering low-level laser therapy, although other allied health professionals can be trained. Blinding the clinicians delivering low-level laser therapy is feasible. There are important human resource, real estate and logistical considerations for those setting up low-level laser therapy services. Future work: Further well-designed randomised controlled trials investigating low-level laser therapy in head and neck cancer irradiation are needed, with similar powered recruitment targets but addressing the recruitment challenges and logistical findings from this research. Trial registration: This trial is registered as ISRCTN14224600. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 46. See the NIHR Journals Library website for further project information.https://doi.org/10.3310/UWNB3375chemoradiotherapylaser therapylow-level light therapymouth mucosamucositisoral cancerphotobiostimulationradiotherapy |
| spellingShingle | Michael Nugent Valerie Bryant Chrissie Butcher Holly Fisher Sean Gill Rebecca Goranova Shaun Hiu Lyndsay Lindley James O’Hara Yemi Oluboyede Joanne Patterson Tim Rapley Tomos Robinson Nikki Rousseau Vicky Ryan Ramkumar Shanmugasundaram Linda Sharp Ruby Smith Whelan Deborah D Stocken Laura Ternent Janet Wilson Jenn Walker Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT Health Technology Assessment chemoradiotherapy laser therapy low-level light therapy mouth mucosa mucositis oral cancer photobiostimulation radiotherapy |
| title | Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT |
| title_full | Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT |
| title_fullStr | Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT |
| title_full_unstemmed | Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT |
| title_short | Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT |
| title_sort | photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation the liteform rct |
| topic | chemoradiotherapy laser therapy low-level light therapy mouth mucosa mucositis oral cancer photobiostimulation radiotherapy |
| url | https://doi.org/10.3310/UWNB3375 |
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