Effectiveness Not Established

Polaprezinc

for Mucositis

Polaprezinc is a compound containing L-carnosine and zinc ion. This compound has been shown to have some positive effects in the treatment of gastric ulcers and other gastrointestinal mucosal injuries. Poaprezinc was examined for its efficacy in the prevention and management of oral mucositis in patients receiving treatment for cancer.

Research Evidence Summaries

Doi, H., Fujiwara, M., Suzuki, H., Niwa, Y., Nakayama, M., Shikata, T., . . . Hirota, S. (2015). Polaprezinc reduces the severity of radiation-induced mucositis in head and neck cancer patients. Molecular and Clinical Oncology, 3, 381–386. 

Study Purpose

To evaluate the feasibility and efficacy of polaprezinc (PZ) for the prevention of oral mucositis (OM) in patients with head and neck cancer receiving radiation therapy

Intervention Characteristics/Basic Study Process

PZ was prepared as an oral rinse (10 ml) and was administered four times per day while patients underwent radiation therapy. The solution was rinsed in the mouth and spat out. Patients were instructed to withhold all food and drink for 30 minutes after rinsing.

Sample Characteristics

  • N = 32  
  • AGE RANGE = 41–86 years
  • MALES: 90%, FEMALES: 10%
  • KEY DISEASE CHARACTERISTICS: Pathologically confirmed head and neck cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients receiving postoperative radiation for chemotherapy were excluded. The most common stage was IVA (n = 11). Most patients had squamous cell cancer (n = 31), and most received 66 Gy (n = 24) radiotherapy. 

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Hospital of Hyogo College of Medicine in Japan

Phase of Care and Clinical Applications

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

Study Design

Nonrandomized, prospective study with a comparative analysis to a case-matched cohort that underwent a retrospective review

Measurement Instruments/Methods

  • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
  • Overall survival, disease-specific survival, and disease-free survival rates were measured.

Results

Overall, 93.8% of patients reported no difficulty with the PZ rinse. Two patients withdrew because of nontolerability. There was no statistic significance between groups for grade 3 mucositis. Some clinical significance in increased ability to take oral nutrition was reported. Quality of life increased, but no measurement of quality of life was provided. There was no difference in survival outcomes.

Conclusions

The use of a PZ oral solution was feasible and may lessen adverse clinical symptoms in regard to OM for patients with head and neck cancer receiving radiation therapy.

Limitations

  • Small sample (< 100)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)

 

Nursing Implications

PZ oral solution, which is a zinc-containing compound, might be helpful in reducing OM and increasing patients’ ability to take oral nutrition. However, more research needs to be completed.

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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.

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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. 

Study Purpose

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

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • 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

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective cohort comparison

Measurement Instruments/Methods

CTCAE, version 3.0

Results

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.

Conclusions

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.

Limitations

  • 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

Nursing Implications

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.

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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. 

Study Purpose

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

Intervention Characteristics/Basic Study Process

  • 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.

Sample Characteristics

  • 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.

Setting

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

Phase of Care and Clinical Applications

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

Study Design

  • 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

Measurement Instruments/Methods

  • 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.

Results

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).

Conclusions

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

Limitations

  • 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)

Nursing Implications

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

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