Svanberg, A., Ohrn, K., & Birgegard, G. (2015). Caphosol mouthwash gives no additional protection against oral mucositis compared to cryotherapy alone in stem cell transplantation. A pilot study. European Journal of Oncology Nursing, 19, 50–53. 

DOI Link

Study Purpose

To determine whether the addition of Caphosol® mouth rinse to a standard of care that included oral cryotherapy would decrease the incidence of oral mucositis

Intervention Characteristics/Basic Study Process

Patients were randomized with a computer table to the experimental or the control group. All patients received oral cryotherapy (crushed ice in the mouth during treatment), but only the experimental group received Caphosol®. Patients in the experimental group used Caphosol® 30 mL to rinse the oral cavity four times per day starting before high-dose chemotherapy and ending on day 21. Data were collected daily from the start of chemotherapy till day 21.

Sample Characteristics

  • N = 40  
  • MEAN AGE = 50.4 years
  • MALES: 23, FEMALES: 17
  • KEY DISEASE CHARACTERISTICS: Hematologic malignancies including acute myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, chronic myelomonocytic leukemia, and myelodysplastic syndrome
  • OTHER KEY SAMPLE CHARACTERISTICS: There were no significant differences between the conditioning regimes of the two groups.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: University Hospital, Sweden

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled, open-label study

Measurement Instruments/Methods

  • World Health Organization (WHO) mucositis grading
  • Pain was assessed using the Visual Analog Scale (VAS).
  • Pain medications, C-reactive protein (CRP) values, lab values, number of total parenteral nutrition (TPN) days, and hospital days were obtained from medical records.

 

Results

There was no statistically significant difference between the mucositis scores, oral pain, days with TPN, use of opioids, number of hospital days, or lab values.

Conclusions

Adding Caphosol® to oral cryotherapy did not provide any additional effects.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Other limitations/explanation: In the experimental group, 15% of patients discontinued the intervention.

Nursing Implications

Oral mucositis continues to be a major complication of chemotherapy, particularity high-dose chemotherapy. Additional research with larger sample sizes is suggested because of a trend of lower pain levels, mucositis scores, and use of analgesics in patients using Caphosol®. The 21-day use of Caphosol® and the discontinuation of Caphosol® because of taste or nausea are other items that merit additional study.