Suzuki, A., Kobayashi, R., Shakui, T., Kubota, Y., Fukita, M., Kuze, B., . . . Itoh, Y. (2016). Effect of polaprezinc on oral mucositis, irradiation period, and time to discharge in patients with head and neck cancer. Head and Neck, 38, 1387–1392. 

To determine whether polaprezinc suspension in sodium alginate (P-AG) reduces the irradiation period and time to discharge after completion of radiotherapy in patients with head and neck cancer and improves the overall survival in patients with head and neck cancer who received radiotherapy

• 104 patients who accomplished 70 Gy of irradiation
• 79 patients received P-AG for prevention of oral mucositis (OM) from May 2009 to December 2014, and 25 patients received azulene gargle for prophylaxis from January 2007 to April 2009.
• Physicians checked the incidence and maximal severity of OM associated with radiotherapy every three days using a fiber-optic camera. 
• Pharmacists and nurses monitored OM and oral pain daily and recorded the results on electronic medical charts.  
• OM was graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Pain was evaluated by a numeric rating scale. 
• The overall survival was plotted by the Kaplan–Meier method and compared statistically between the control group and the P-AG group by the Mantel–Cox log-rank test.

• N = 25 (control group), 79 (P-AG group)    
• AGE = 64.5 (49.8–75.6) (control group) and 65.7 (50.8–78) (P-AG group) 
• MALES: 90, FEMALES: 14
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: The control group primary site of cancer was the larynx (36%), followed by the oropharynx/ hypopharynx and epipharynx. The P-AG group primary site was the larynx (43%) and oropharynx/ hypopharynx (43%).
• OTHER KEY SAMPLE CHARACTERISTICS: Of the patients in both groups, 40%–45% had no lymph node metastasis. The most common chemotherapy regimen was docetaxel (36%), followed by cisplatin 5-fluorouracil (CDDP/5-FU) and carboplatin in the control group, whereas CDDP/5-FU (34%) followed by carboplatin and docetaxel was provided for the P-AG group.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Gifu University Hospital, Japan

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

• Retrospective study to assess the incidence and severity of OM, the irradiation period, and the time to discharge in patients who received radiotherapy for head and neck cancer

• Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as follows: grade 1 = erythema of the mucosa in oral cavity; grade 2 = patchy ulcerations or pseudomembranes in the oral cavity; grade 3 = confluent ulcerations or pseudomembranes, or bleeding with minor trauma in the oral cavity; and grade 4 = life-threatening consequences in the oral cavity
• Pain was evaluated by a numeric rating scale.
• The Mantel–Cox log-rank test for the overall survival was plotted by the Kaplan–Meier method.

The incidence of grade 3 OM was significantly lower in the P-AG group than in the control group (16.5% versus 52%, p = 0.0003). P-AG also significantly reduced the median duration of radiotherapy (HR = 0.557, 95% CI [0.357, 0.871], p = 0.0149) and median time to discharge after completion of radiotherapy (HR = 0.604, 95% CI [0.386, 0.946], p = 0.028).

P-AG was useful for preventing OM and reducing the irradiation period and median time to discharge after the completion of radiotherapy.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Retrospective study to assess patients who received P-AG (n = 79) for prevention of OM or azulene gargle (n = 25)

Randomized and multi-institutional designs are needed to clarify the beneficial effect of P-AG on the incidence of OM and hospitalization.