The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial

Abstract

Oral mucositis (OM) is a complication of high-dose chemotherapy (HDC) followed by hematopoietic SCT (HSCT) with few effective treatments. Selenium has a cytoprotective role via the glutathione peroxidase (Glu.Px) enzyme and prevents chemotherapy-induced toxicities. We performed a double-blind, randomized, placebo-controlled study to evaluate the efficacy of selenium on the prevention of OM in 77 patients with leukemia, undergoing allogeneic HSCT. Thirty-seven patients received oral selenium tablets (200 mcg twice daily) from the starting day of HDC to 14 days after transplantation. OM was evaluated daily for 21 days after transplantation according to World Health Organization oral toxicity scale. The incidence of severe OM (grades 3-4) was significantly lower in the selenium group (10.8% vs 35.1%, Po0.05). We noted that the duration of objective OM (grades 2-4), excluding patient's selfdeclaration (grade 1), was significantly shorter in the selenium group (3.6 ± 1.84 vs 5.3 ± 2.2 days, P ¼ 0.014). Significant elevations in serum selenium level and plasma Glu.Px activity were observed 7 and 14 days after transplantation compared with baseline in the selenium group. We conclude that selenium can reduce the duration and severity of OM after HDC.

N-acetyl cysteine for prevention of oral mucositis in hematopoietic SCT: a double-blind, randomized, placebo-controlled trial

“…In addition, we noted that no patient in the NAC group developed grade 4 OM, the most unbearable form of OM, in which oral alimentation is impossible. These findings are in agreement with the results of the study performed by Jahangard-Rafsanjani et al 9 Our results with NAC is also comparable with palifermin, which has been shown to reduce the incidence of grade 4 OM. 32 Palifermin is currently the only drug approved by the US Food and Drug Administration for the prevention of OM in patients with hematologic malignancies who receive HDC.…”

“…33 In comparison with palifermin, NAC is relatively inexpensive and has no considerable interactions with antineoplastic drugs. [34][35][36][37] In our study, the overall duration of OM was also significantly shorter in the NAC group whereas in Jahangard-Rafsanjani et al 9 study, only the mean duration of severe OM (grade 3-4) was significantly lower in the intervention group (selenium). However, none of the agents could alter time to onset of OM.…”

“…10,31 However, our previous study revealed that zinc sulfate could not have any clinical benefits to the prevention of OM or reduction of its severity. 22 In a study by Jahangard-Rafsanjani et al 9 on the efficacy of selenium for the prevention of OM, selenium reduced the incidence and the duration of severe OM (grades 3-4).…”

“…We assumed that NAC may reduce OM incidence to 30%, considering a confidence interval of 95%, and a statistical power of 80%. 9,[22][23][24] Forty participants were required in each study group and balanced block randomization method was used to allocate patients to the study groups.…”

“…There are several studies regarding the effects of antioxidant agents such as vitamin E, β-carotene, selenium and zinc sulfate with different results on prevention of OM induced by chemotherapy and/or radiation therapy. [7][8][9][10] N-acetyl cysteine (NAC), an antioxidant containing thiol groups, is a form of amino-acid cysteine, which is widely used as mucolytic agent or an antidote for acetaminophen overdose hepatotoxicity. NAC stimulates glutathione synthesis and scavenges free radicals.…”