Mucosite Mouthwash

Mucosite Mouthwash

PEP Topic 
Mucositis
Description 

Mucosite mouthwash is a solution composed of verbascoside (a chemical present in many plants used for flavoring and medicines that has antioxidant properties) and sodium hyaluronate (a chemical found in the body that holds moisture and has been shown to facilitate wound healing).

Effectiveness Not Established

Research Evidence Summaries

Bardellini, E., Amadori, F., Schumacher, R.F., D'Ippolito, C., Porta, F., & Majorana, A. (2016). Efficacy of a solution composed by verbascoside, polyvinylpyrrolidone (PVP) and sodium hyaluronate in the treatment of chemotherapy-induced oral mucositis in children with acute lymphoblastic leukemia. Journal of Pediatric Hematology/Oncology, 38, 559–562. 

doi: 10.1097/MPH.0000000000000669
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Study Purpose:

To determine the efficacy of a mouthwash solution composed of verbascoside, polyvinylpyrrolidone, and sodium haluronate (Mucosyte) in the treatment of chemotherapy-induced oral mucositis (OM)

Intervention Characteristics/Basic Study Process:

Patients undergoing chemotherapy for acute lymphoblastic leukemia (ALL) on the same protocol treatment (ALL 2009 standard protocol) were included in the study. Patients were randomized to either the group A (intervention group) or group B (placebo group). Each group were to rinse with 15 ml of the solution for two minutes three times a day for a total of eight days. OM scoring was conducted on day 1 (day of diagnosis of OM), three days after treatment, and again on day 8. Pain scores were determined at the same time as the oral examination for the OM scoring.

Sample Characteristics:

  • N = 56   
  • AGE = 5–18 years
  • MALES: 9 (intervention), 13 (placebo), total = 39%  
  • FEMALES: 19 (intervention), 15 (placebo), total = 61%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: ALL
  • OTHER KEY SAMPLE CHARACTERISTICS: Grade 1 or 2 OM

Setting:

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

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design:

Randomized, double-blinded study. Each participant was randomized with an automatically generated list.

Measurement Instruments/Methods:

  • Common Toxicity Criteria for Adverse Events (CTCAE) and scale of the WHO to grade OM
  • Visual analog scale (VAS) used to score pain level

Results:

Group A showed a reduction in OM of T1 on day 3. On day 8, group A and group B had a reduction of T2, with group A revealing a statistically significant decline compared to group B (p = 0.0038). Group A showed a reduction in pain scores for both TI and T2, resulting in a reduction in additional analgesia needed, compared to group B.

Conclusions:

The use of Mucosyte mouthwash in children with chemotherapy-induced OM revealed a reduction in the grade of OM and pain scores during an eight-day treatment and, therefore, may be recommended as a supportive treatment.

Limitations:

Small sample (< 100)

 

Nursing Implications:

The implications of this study are promising for treatment with Mucosyte mouthwash for reducing OM and pain during chemotherapy for ALL. More studies may need to be conducted, because this study took into account only patients on the same treatment regimen. Other treatment regimens including chemotherapy, radiation, and or laser therapy may affect the severity and duration of OM and, therefore, may reveal different results.

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