Hayashi, H., Kobayashi, R., Suzuki, A., Ishihara, M., Nakamura, N., Kitagawa, J., . . . Itoh, Y. (2014). Polaprezinc prevents oral mucositis in patients treated with high-dose chemotherapy followed by hematopoietic stem cell transplantation. Anticancer Research, 34, 7271–7277. 

Study Purpose

To investigate whether polaprezinc is effective in preventing oral mucositis (OM) in patients receiving high-dose chemotherapy and radiation followed by hematopoietic stem cell transplantation (HSCT)

Intervention Characteristics/Basic Study Process

The treatment group received polaprezinc alginate (P-AG) solution rinses four times per day for one month after transplantation. The control group received an azulene oral rinse four times per day for one month after transplantation.

Sample Characteristics

  • N = 36 (25 treatment, and 11 control)   
  • AGE RANGE = 15–66 years
  • MALES: 40% (treatment); 64% (control); 47% (overall), FEMALES: 60% (treatment); 36% (control); 53% (overall)
  • KEY DISEASE CHARACTERISTICS: Hematologic malignancies

Setting

  • SITE: Single site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: Medium-sized university hospital in Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics and elder care  

Study Design

Retrospective study

Measurement Instruments/Methods

  • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
  • The amount of analgesia used was recorded.  
  • Parametric and nonparametric statistics (T test, chi-square, Mann-Whitney, and P value of < 0.05 for significance)

Results

P-AG decreased the incidence of grade 2 or greater OM. The average grade of OM was lower in the P-AG group. There was a decrease in the amount of moderate to severe pain.

Conclusions

P-AG might be effective in lowering the incidence and severity of OM in patients receiving high-dose chemotherapy and radiation followed by HSCT.

Limitations

  • Small sample (< 30)
  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable

 

 

Nursing Implications

P-AG may help in the prevention of OM, but additional study is warranted before a practice change is recommended.