Trial reportBMC cancer2026
Effect of alpha-lipoic acid on salivary secretion in patients undergoing head and neck radiotherapy: a randomized clinical trial.
Trial report in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
6 authors.
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Abstract
backgroundRadiation-induced hyposalivation is a common and debilitating side effect of head and neck radiotherapy, significantly impairing patients’ quality of life. Alpha-lipoic acid (ALA), a potent antioxidant, is hypothesized to enhance salivary secretion and promote the regeneration of acinar cells. Our study aimed to evaluate the effect of ALA on unstimulated salivary flow rate in patients undergoing head and neck radiotherapy.
methodsThis double-blind, randomized controlled clinical trial included 20 patients undergoing head and neck radiotherapy. Participants were randomly assigned to the intervention group (receiving 1200 mg/day ALA) or to the control group (receiving placebo) for three months. Unstimulated whole salivary flow rate (mL/min) was measured using the spitting method at baseline (pre-radiotherapy) and at weeks 2, 6, 8, and 12 post-radiotherapy. Xerostomia severity was assessed using the Numeric Rating Scale (NRS), alongside clinical signs of hyposalivation (e.g., frothy saliva, mucosal adherence). Data were analyzed using t-tests and Fisher’s exact test in SPSS version 25.00, with a significance level of 0.05.
resultsAlthough both groups indicated a decline in salivary flow over time, no significant intergroup differences were observed at any follow-up point (P > 0.05). Within the ALA group, pairwise comparisons revealed a significant reduction in salivary flow from baseline to weeks 6, 8, and 12 (P = 0.02, P = 0.01, and P = 0.003, respectively). Additionally, a significant reduction was observed between weeks 2 and 6 (P = 0.011). No significant differences between groups were found in NRS scores or clinical indicators of hyposalivation during any follow-up session (P > 0.05).
conclusionsAdministration of 1200 mg/day ALA may temporarily delay the onset of salivary gland dysfunction in the early phases of radiotherapy. However, this effect was not statistically significant and may not have a sustained clinical benefit.
trial registrationThis clinical trial was approved by the Research Ethics Committee of Shahid Beheshti University of Medical Sciences (IR.SBMU.DRC.REC.1401.062) and registered in the Iranian Registry of Clinical Trials (IRCT20221219056864N1, registered on December 19, 2022).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.