Alpha-lipoic acid as a preventive measure in radiation-induced oral mucositis in head and neck cancer patients: A randomized controlled study

Abstract

Aim: Alpha-lipoic acid (ALA), a potent antioxidant, anti-inflammatory and cytoprotective drug, has revealed potential efficacy in pre-clinical studies in reducing radiation induced oral mucositis (RIOM). This study aims to evaluate the protective effects of ALA on RIOM. Methods: In this randomized controlled study, 70 head and neck cancer (HNC) patients receiving definitive radiotherapy were assigned to receive either oral ALA (600 mg twice daily) or placebo tablets throughout the radiotherapy period. The primary outcome was the assessment of the incidence and severity of RIOM using the Radiotherapy Oncology Group (RTOG) grading system. Secondary outcomes were the onset and duration of severe RIOM (Grades 3 and 4), quality of life (QOL), and serum total antioxidant capacity (TAC) and C-reactive protein (CRP). Results: The incidence of severe RIOM was 16.7% with the use of ALA, while in the control group it was 41.3% (p value = 0.036). Moreover, ALA significantly delayed the occurrence of severe RIOM (p value = 0.033) and resulted in significantly shorter healing time (p value = 0.042). At the end of the study, ALA resulted in a mean percent change in QOL score from baseline of 43.33, which was non-significantly different from the control group with a mean of 44.84. ALA significantly improved TAC levels but had no effect on CRP. The use of ALA was safe and tolerable. Conclusion: ALA showed a significant reduction in the severity and delayed the onset of RIOM with a high safety profile through its potent antioxidant effects.