Effectiveness Not Established


for Mucositis

Erythropoietin (EPO) is an essential hormone that has anti-inflammatory, antioxidant, and wound-healing properties, and helps control red blood cell production. An EPO-based mouthwash was examined for its effect on the prevention and management of mucositis in patients with cancer undergoing hematopoietic cell transplantation.

Research Evidence Summaries

Hosseinjani, H., Hadjibabaie, M., Gholami, K., Javadi, M., Radfar, M., Jahangard-Rafsanjani, Z., . . . Ghavamzadeh, A. (2015). The efficacy of erythropoietin mouthwash in prevention of oral mucositis in patients undergoing autologous hematopoietic SCT: A double-blind, randomized, placebo-controlled trial. Hematological Oncology. Advance online publication.

Study Purpose

To evaluate the use of erythropoietin (EPO) for the prevention and reduction of oral mucositis (OM) in patients undergoing autologous hematopoietic stem cell transplantation

Intervention Characteristics/Basic Study Process

The intervention group used EPO mouthwash (50 IU/ml, 15 ml) four times per day beginning on the day of conditioning initiation and for 14 days post transplant or until DC, whichever came first. The control group received mouthwash (15 ml) four times a day without EPO for the same period of time. The mouthwash looked, smelled, and tasted the same. All patients were evaluated daily until day 21 by the same blinded evaluator. The World Health Organization (WHO) Oral Toxicity Scale was used for assessment.

Sample Characteristics

  • N = 80 (40 in intervention group, 40 in control group)   
  • AGE = Older than 18 years (mean age was 43.37 years in the treatment group; mean age was 45.07 years in the control group)
  • MALES: 51.25% overall (55% intervention group, 47.5% placebo group); FEMALES: 48.75% (45% intervention group, 52.5% placebo group)
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Non-Hodgkin lymphoma, Hodgkin lymphoma, and multiple myeloma; active treatment
  • OTHER KEY SAMPLE CHARACTERISTICS: All undergoing autologous stem cell transplantation


  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Iran

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Palliative care 

Study Design

  • Double-blinded, randomized controlled trial

Measurement Instruments/Methods

  • WHO Oral Toxicity Scale
  • Length of stay
  • Duration of neutropenia and thrombocytopenia
  • Engraftment time
  • Incidence and length of neutropenic fever
  • Number of transfusions (platelets and packed cells)
  • Use of parenteral opioid narcotics


Overall, less OM occurred in the EPO group (p < 0.001), less grade 2–4 OM occurrend in the EPO group (p = 0.003), and no significant difference existed in severe OM (grades 3–4) between groups, but the trend was less in the EPO group. Less intensity and severity of OM occurred in the EPO group (p < 0.001), shorter duration of OM occurred in the EPO group (p < 0.001), and the duration of neutropenic fever was less in the EPO group (p = 0.016). No differences in hematologic recovery, duration of neutropenia, or length of stay existed across groups. In addition, no differences in parenteral opioid use and transfusion were present across groups.


EPO mouthwash reduced the overall incidence of OM, decreased the severity and intensity of OM, and decreased the duration of OM. The duration of neutropenic fever was also decreased. A trend toward less severe OM (grades 3–4) in patients who used the EPO mouthwash was present.


  • Small sample (< 100)
  • Findings not generalizable
  • This is the first RCT. The dose of EPO prior to this study has not been studied for the prevention of OM. The patient population studied is limited to high-dose chemotherapy and autologous stem cell transplantation.

Nursing Implications

EPO mouthwashes hold promise for preventing OM in patients undergoing autologous stem cell transplantation and receiving high-dose chemotherapy. Additional study is indicated, and the investigation of EPO mouthwash dosing will be important. The cost of EPO mouthwash may be an issue and will need to be evaluated.