Therapeutic effect of Photobiomodulation therapy on radiation-induced oral mucositis in head and neck Cancer: A prospective double-blind, self-controlled clinical trial.

BACKGROUND

Oral mucositis (OM) is a common and painful complication in patients with head and neck cancer (HNC) undergoing radiotherapy or chemoradiotherapy. Photobiomodulation therapy (PBMT) historically referred to as low-level laser therapy (LLLT) has been suggested as a treatment for reducing OM severity and pain.

METHODS

In this prospective, double-blind clinical trial, 163 patients were screened, and 53 patients with two comparable OM lesions were ultimately included in the analysis. One lesion received PBMT (660 nm, 150 mW, 5 J per point, twice weekly), and the other received sham treatment as control. Lesion severity and pain were assessed weekly using the Oral Mucositis Assessment Scale (OMAS) and the Visual Analog Scale (VAS) until complete healing or two weeks after radiotherapy.

RESULTS

PBMT significantly reduced OMAS and VAS scores compared to control lesions. VAS reduction was observed from the first week, whereas OMAS decreased from week three. Complete healing occurred in 52.4% of intervention lesions versus 11.9% of control lesions (P < 0.001). PBMT accelerated recovery without adverse effects. According to multivariable regression analysis, Primary cancer site was the independent predictive factor of healing of radiation-induced oral mucositis following PBMT (aOR 5.78, 95% CI 1.28-36.0, P = 0.03).

CONCLUSIONS

PBMT was associated with a significant reduction in pain and lesion severity in patients with radiation-induced oral mucositis undergoing head and neck radiotherapy. These findings support its potential therapeutic role as a supportive care intervention.