Hayashi, H., Kobayashi, R., Suzuki, A., Yamada, Y., Ishida, M., Shakui, T., . . . Itoh, Y. (2016). Preparation and clinical evaluation of a novel lozenge containing polaprezinc, a zinc-L-carnosine, for prevention of oral mucositis in patients with hematological cancer who received high-dose chemotherapy. Medical Oncology, 33, 91-016-0795-z. 

To evaluate the clinical effect of a newly developed lozenge containing polaprezinc for the prevention of oral mucositis in patients who received conditioning high-dose chemotherapy for hematopoietic stem cell transplantation (HSCT) compared to a polaprezinc (zinc-L-carnosine) suspension in a sodium alginate solution that has been shown to be effective in the prevention of oral mucositis in patients who received radiotherapy or high-dose chemotherapy

Patients were pretreated with either polaprezinc suspension during January 2013 and December 2014 or polaprezinc lozenge during January 2015 and December 2016 for the prevention of oral mucositis. The control group consisted of patients who received high-dose chemotherapy without any premedication during March 2006 and February 2011. The incidence and severity of oral mucositis and its associated symptoms, such as oral pain, were reviewed from medical records and compared among the three groups. The severity of adverse events was graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.

• N = 66
• AGE RANGE = 19–70 years
• MALES: Not given  
• FEMALES: Not given 
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, acute lymphoblastic leukemia, acute promyelocytic leukemia, myelodysplastic, natural killer/T-cell lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, Hodgkin lymphoma

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

PHASE OF CARE: Active antitumor treatment

Retrospective cohort comparison

CTCAE, version 3.0

The results showed grade 2 and grade 3 oral mucositis in the no-premedication control group. The polaprezinc suspension group and the polaprezinc lozenge group showed less incidence of grade 2 mucositis, and the overall average grade of oral mucositis was 0.6 for the suspension group and lozenge group. No statistical difference existed in the average grade or incidence rate of oral mucositis between the suspension group and lozenge group.

The newly developed lozenge containing polaprezinc for the prevention of oral mucositis was shown to be highly effective in the prevention of moderate to severe oral mucositis in patients receiving high-dose chemotherapy for HSCT. There was some question about the efficacy of the lozenge preparation when compared to the suspension.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results 
• Measurement/methods not well described
• Intervention expensive, impractical, or training needs

Gender was not clearly identified, and the method of evaluating the grade of mucositis was not clearly described. The lozenge is not a readily available product, developed and compounded for this study. The product has promise if the study is replicated as randomized, controlled trial.