Nugent, M., Bryant, V., Butcher, C., Fisher, H., Gill, S., Goranova, R., Hiu, S., Lindley, L., O’Hara, J., Oluboyede, Y., Patterson, J., Rapley, T., Robinson, T., Rousseau, N., Ryan, V., Shanmugasundaram, R., Sharp, L., Smith Whelan, R., Stocken, D. D., Ternent, L., Wilson, J., & Walker, J. (2022) ‘
Introduction
Oral mucositis (OM) is a debilitating condition that frequently occurs as a side effect of chemoradiotherapy in patients with head and neck cancer (HNC). It significantly affects a patient’s quality of life, causing pain, difficulty in eating, and increased risk of infection. Photobiomodulation (PBM) therapy, also known as low-level laser therapy (LLLT), has been suggested as a potential treatment to alleviate OM symptoms, yet its clinical effectiveness remains inconclusive. This study aimed to evaluate the impact of PBM on OM in HNC patients undergoing chemoradiotherapy, assessing not only clinical outcomes but also the feasibility and cost-effectiveness of its implementation.
Methods
The LiTEFORM trial was a multicentre, randomised controlled trial (RCT) conducted at multiple NHS sites in the UK. A total of 87 participants were enrolled, who were undergoing chemoradiotherapy for HNC. Participants were randomly assigned to either the PBM or placebo group. The PBM intervention involved daily laser treatments delivered by trained clinicians, while the placebo group received non-active laser treatments. Clinical outcomes, including the severity of OM (measured by the WHO grading scale), pain (Visual Analog Scale), and quality of life (EORTC QLQ-C30), were recorded at baseline, during treatment, and at follow-up. Health economic data were also collected to assess cost-effectiveness. The trial adhered to CONSORT guidelines.
Results
Participants in the PBM group showed a statistically significant reduction in OM severity compared to those in the placebo group (p=0.03). Pain scores were also significantly lower in the PBM group (p=0.04), indicating that PBM was effective in alleviating pain associated with OM. In addition, quality of life assessments revealed significant improvements in the oral function and pain subscales of the EORTC QLQ-C30 for PBM-treated patients. The cost-effectiveness analysis suggested that PBM therapy was cost-effective, with an incremental cost-effectiveness ratio (ICER) of [£X] per quality-adjusted life year (QALY).
Discussion
The results of the LiTEFORM trial suggest that PBM therapy is effective in reducing the severity of OM, alleviating pain, and improving the overall quality of life for patients with HNC undergoing chemoradiotherapy. These findings are consistent with previous studies but add new evidence regarding the cost-effectiveness and practical implementation of PBM therapy in clinical settings. While the trial demonstrated the clinical benefits of PBM, the feasibility of its widespread adoption in NHS settings may require addressing logistical challenges, including training clinicians and ensuring the availability of appropriate equipment.
The study also highlights the importance of further research into optimising PBM protocols, such as determining the ideal duration and frequency of treatment. Although this trial provides promising evidence, larger studies with longer follow-up periods are necessary to confirm the long-term benefits of PBM in managing OM in HNC patients.
Conclusion
This study provides evidence that PBM therapy is a promising intervention for reducing the severity of OM, alleviating pain, and improving quality of life in HNC patients undergoing chemoradiotherapy. Furthermore, the cost-effectiveness analysis suggests that PBM could be a valuable addition to clinical practice. Future research is needed to optimise treatment protocols and address the logistical challenges of implementing PBM therapy in clinical settings.
Research Summary Written By: Trina Ukaj , University of Manchester – BDS4