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. 

DOI Link

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.