Salivary Methotrexate as a Predictor of Oral Mucositis in Hematological Cancer Patients: A Phase II Randomized, Double-Blind Clinical Trial.
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Rodrigues-Oliveira Letícia, Bonfim Carolina Guimarães, Mores Ana Leticia, Palmier Natalia Rangel, Abdalla Henrique Ballassini, Clemente-Napimoga Juliana Trindade, Aquino Iara Gonçalves, de Oliveira Maria Cecilia Querido, Cuzzullin Maria Cláudia, Filho Aljomar Jose Vechiato, Rivera Cesar, Toporcov Tatiana Natasha, Pereira Juliana, Gueiros Luiz Alcino, López Rossana Veronica Mendoza, Martins Manoela Domingues, Lamers Marcelo Lazzaron, Morais-Faria Karina, Vargas Pablo Agustin, Santos-Silva Alan Roger, Brandão Thais Bianca, Prado-Ribeiro Ana Carolina
Аннотация
METHODS: This phase II randomized, double-blind, placebo-controlled trial enrolled adults with hematological malignancies undergoing a first HD-MTX cycle at a tertiary cancer center in Brazil. Participants were randomized to PBMT or sham laser therapy, administered daily until MTX clearance or for up to five sessions. OM was assessed for 9 days using WHO criteria. Serum and salivary MTX concentrations were measured at 24, 48, and 72 h post-infusion, along with urinary pH and serum creatinine.
RESULTS: Fifty-three patients were randomized (PBMT n = 26; placebo n = 27). PBMT significantly reduced ulcerative OM (grade ≥ 2) at 96 h (11.5% vs. 51.9%), yielding a 77.7% relative risk reduction and a number needed to treat of 2 (p < 0.01). Placebo recipients had an 8.97-fold higher odds of severe OM. Serum MTX was not associated with OM, whereas salivary MTX increased disproportionately over time and independently correlated with OM severity.
CONCLUSIONS: PBMT significantly reduced OM incidence and severity in adults receiving HD-MTX. Salivary MTX is a promising non-invasive biomarker for OM risk.
TRIAL REGISTRATION: Trial was prospectively registered in the Brazilian Registry of Clinical Trials (ReBec, No. 12218).