Mehdipour, M., Taghavi, Z., A., Asvadi, K., I., & Hosseinpour, A. (2011). A comparison between zinc sulfate and chlorhexidine gluconate mouthwashes in the prevention of chemotherapy-induced oral mucositis. Daru Journal of Faculty of Pharmacy Tehran University of Medical Sciences, 19(1), 71-73.

 To evaluate the effectiveness of a zinc-containing mouthwash on chemotherapy-induced oral mucositis in comparison with chlorhexidine gluconate mouthwash as control.

Patients with acute myeloid leukemia under chemotherapy were allocated to an experimental and control groups of 15 patients each. The required dilution of 0.2% zinc sulphate and chlorhexidine gluconate mouthwashes. Subjects instructed to rinse with 10 ml of 0.2% zinc sulphate mouthwash twice a day for 14 days in the experimental group. The control group used 0.2% chlorhexidine mouthwash in the same manner. The mouthwashes were coded with A and B letters on the bottles, and the investigator, as well as the subjects were blinded to the type of the mouthwash, which was administered to the groups by a simple random method. All subjects were examined every other week for eight weeks.

The study was comprised of 30 patients, over 15 years of age.

MALES (%) Not specified, FEMALES (%) Not specified

KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia

OTHER KEY SAMPLE CHARACTERISTICS: Subjects receiving an established treatment plan of Cytarabine in the induction phase and Novantrone in the consolidation phase were included in the study. Exclusion criteria included no subject <15 years of age. Allergy to zinc or chlorhexidine mouthwashes. Any systemic disease with other diagnosis of malignancies or chemotherapy-induced oral mucositis, any oral ulcers, or mucositis developed before starting chemotherapy.
 

SITE: Single site

LOCATION: The oncology ward of Shahid Gazi Hospital in Tabriz, Iran

PHASE OF CARE: Active treatment

APPLICATIONS: Acute myeloid leukemia

Randomized, double-blind, controlled

• Instrument: Spijkervet Scale was used to grade the severity of Mucositis    
• Observation: The efficacy of the treatment at each session was determined by recording the length (E) of the lesion, measured by a digital caliper, and its severity (K), based on local signs.
• Observation: Eight distinguishable irradiated areas of the mouth including buccal mucosa (left and right), soft and hard palate, dorsum and border of the tongue (left and right), and the floor were evaluated.
• Observation: The score of each area was defined as the product of the length and severity score from the Spijkervet Scale. The mucositis score (alpha) in each individual was defined as the mean of the scores assigned to the evaluated areas, and ranged from 0-16.
• Observation: Independent t-test used for evaluation of any probability of differences between the groups in regard to baseline.
   

There were no significant differences between the case and control groups in the first week (p = 0.124). The trends of changes in the assessed oral mucositis index during the course of the study were similar in both groups. The mean a (alpha) index in both groups increased from the first week to the third week and then decreased in the fourth week. Although the mean a (alpha) index was generally lower in the test group compared to the control  group at all four time intervals evaluated, repeated measure ANOVA revealed that the difference was statistically significant in weeks 2 and 3 (p = 0.025).

 Zinc mouthwash used in conjunction with chemotherapy may reduce the severity of oral mucositis lesions in patients with leukemia.

•  Small sample <100
•  Lack of  ability to generalize. Lack of the prophylactic agent (zinc) at different concentrations.  
   

The double-blind study is the most efficacious. Within the field of oncology, the occurrence of mucositis has always been associated as a side effect of chemo-radiation therapies. Mucositis is a result of radiotherapy and chemotherapy or a combination of the two. Thus, mucositis needs immediate and timely nursing interventions. The zinc mouthwash appears to be cost effective and easy to use. To this, clinical trials with randomized testing within the United States that support zinc mouthwash may be beneficial. Nurses who are in the oncology setting face challenges to plan and provide care that promotes the best possible health related outcomes for their patients.