Jahangard-Rafsanjani, Z., Gholami, K., Hadjibabaie, M., Shamshiri, A.R., Alimoghadam, K., Sarayani, A., . . . Ghavamzadeh, A. (2013). The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: A randomized clinical trial. Bone Marrow Transplantation, 48, 832–836.

To evaluate the efficacy of selenium intake for prevention of oral mucositis (OM) in patients with hematologic malignancies who are candidates for allogeneic hematopoietic stem cell transplantation (HSCT) after receiving high-dose chemotherapy (HDC)

Patients randomly were assigned to the selenium or control group in a blocked, randomization schedule. They were given either a selenium tablet (200 mcg) or placebo tablet twice daily, from the starting day of HDC to 14 days after transplantation. Chemotherapy was the same for all patients. All patients received a similar regimen for prevention of mucositis, including nystatin, sucralfate, and mouthwashes with chlorhexidine, plus 10 cc diluted povidone-iodine every three hours. Narcotic analgesics rarely were used to alleviate OM.

• N = 77 patients participated, 74 patients completed, and 3 patients discontinued
• MEAN AGE = 33.3 years
• MEDIAN AGE: 32 years
• RANGE: 18–55 years
• MALES: 56%, FEMALES: 44%
• KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL)
• OTHER KEY SAMPLE CHARACTERISTICS: Disease status before transplant was evenly matched in the study and control group.

• SITE: Hematology-Oncology and Stem Cell Transplantation Research Center    
• SETTING TYPE: Shariati Hospital  
• LOCATION: Tehran, Iran

• PHASE OF CARE: Treatment
• APPLICATIONS: Adult patients with AML or ALL undergoing allogeneic HSCT

• Double-blind, randomized, controlled study

• Five-grade World Health Organization (WHO) toxicity scale for OM
  • Assessment was carried out by one author under the supervision of the attending physician; both were blinded to patients’ allocation.
  • Assessed on a daily basis (except for weekends and holidays)
  • Assessed from day one of HDC until 21 days after transplantation, or until OM was resolved

The cumulative incidence of OM (WHO scale grades of 1–4) in the selenium group and control group was not significantly different. The incidence of severe OM (grades 3 and 4) was significantly lower in the selenium group (10.8% versus 35.1%, P = 0.013). Two patients in the control group experienced WHO OM grade 4, and none of the patients in the selenium group experienced grade 4. Mean duration of OM was not different between the two groups. Mean duration of OM from the beginning of grade 2, moving up to grade 4, and then returning to grade 2 was significantly lower in the selenium group. No difference was seen in the start day of OM between the two groups.

Selenium supplementation during HDC may prevent severe OM in patients undergoing allogeneic HSCT. Further testing is needed before selenium can be recommended. Further testing is needed to establish optimal dose, time to initiate, and duration of treatment with selenium.

• Small sample: < 100
• Single institution
• No mention of how the outcome assessor was trained to do the assessments
• Authors contradicted themselves when they stated no patients in the selenium group experienced grade 4 OM, yet also stated in the results that mean duration from beginning of grade 2, moving up to grade 4, and returning to grade 2 was significantly lower in the selenium group.

Nurses need to be informed about possible effective methods for reducing and eliminating OM to guide their patients.