Intravenous selenium to prevent oral mucositis in patients with lymphoma or myeloma undergoing high-dose therapy followed by autologous hematopoietic cell transplantation: A double-blind randomized trial.

Abstract

12091 Background: Oral mucositis (OM) is a frequent complication in patients with lymphoma and myeloma receiving high-dose therapy (HDT) and autologous hematopoietic cell transplantation (HCT) that can lead to severe pain, malnutrition due to difficulties in drinking and eating, and local and systemic infections. In severe cases, patients require opioid analgesics, supplemental nutrition, and additional antimicrobial therapy while very few preventive interventions have proven useful. Because of its anti-oxydant activity, some studies have suggested that selenium could be useful in this context. We therefore led a double-blind randomized trial to evaluate the use of selenium in preventing OM in patient with lymphoma or myeloma receiving HDT (NCT04080622). Methods: Patients ≥18 years with lymphoma or myeloma undergoing HDT (carmustine, etoposide, cytarabine, and melphalan [BEAM] for patients with lymphoma and high-dose melphalan for patients with myeloma) followed by autologous HCT were randomized beween intravenous selenium 300 µg/day or placebo from the first day of chemotherapy to hospital discharge. The primary endpoint was the incidence of severe (grade 3-4) OM by intention to treat as defined by the World Health Organization (WHO). Secondary endpoints included any grade oral mucositis (WHO), auto and hetero-évalaution (NCI-CTCAE) of OM, opioid, nutrition, and antimicrobial therapy used, duration of hospitalization, and adverse events (AE). Results: From October 2019 to October 2023, we included 100 patients with lymphoma (n = 29) and myeloma (n = 71) who received HDT and autologous HCT that were randomized between selenium (n = 50) and placebo (n = 50). Baseline characterstics (age, gender, and tobacco use, type of hematologic disease, disease status at HDT, and baseline albumin and selenium levels) were balanced between the two treatment arms. The rate of severe OM was strictyl identical in both arms (60%, P = 1) with a mean maximum grade of mucositis of 3.26 in the selenium arm and 2.82 in the placebo arm ( P = 0.71). Other methods to evaluate OM showed similar results. Opioid use (mean 6.92 versus 6.12 days in the placebo group, P = 0.53), parenteral nutrition (mean 10.88 versus 9.27 days, P = 0.19), antibiotic use (9.12 versus 7.02 days, P = 0.05), antifungal use (1.02 versus 0.39 days, P = 0.33), and duration of hospitalization (24.94 versus 19.58 days, P = 0.24) were not statistically different between the two groups. The rate of grade 3-4 AE was higher in the selenium arm (100% versus 90%, P = 0.03) with similar rates of grade 3-4 diarrhea (10% versus 16%, P = 0.55). Conclusions: Intravenous selenium did not improve oral mucositis in patients with lymphoma or myeloma undergoing HDT followed by autologous HCT. Clinical trial information: NCT04080622 .