Papadeas, E., Naxakis, S., Riga, M., & Kalofonos. C. (2007). Prevention of 5-fluorouracil-related stomatitis by oral cryotherapy: A randomized controlled study. European Journal of Oncology Nursing, 11, 60–65.

DOI Link

Intervention Characteristics/Basic Study Process

  • Patients were instructed to swish around crushed ice cubes in their oral cavity from 5 minutes before until 30 minutes after IV administration of 5-fluorouracil (5-FU).
  • Physician evaluators were blinded.
  • Patients received five consecutive days of leucovorin (20 mg/m2 per day) plus 5-FU (600 mg/m2 per day) administered over a few minutes (Mayo regimen).
  • Patients were evaluated for three consecutive cycles.

Sample Characteristics

  • The cryotherapy group consisted of 36 patients. Mean age was 62.6 years, with a range of 50–82 years. 
  • The control group consisted of 40 patients. Mean age was 61 years, with a range of 42–78 years.
  • Patients with head and neck cancer were excluded.
  • Nine patients were unwilling to join the cryotherapy group because of tolerance to oral ice.

Measurement Instruments/Methods

  • Patients were instructed to complete a questionnaire one month after cryotherapy prior to the following course.
  • Two blinded otorhinolaryngologists graded patients on a 0–4 scale.

Results

  • The percentage of patients free from oral toxicity was significantly higher in the cryotherapy arm (p < 0.01) based on physician evaluations.
  • The percentage of patients not suffering from mucositis was significantly higher in the cryotherapy arm following the first and third cycles (p < 0.05) but also after the second chemotherapy cycle (p < 0.01).

Limitations

  • Researchers were unable to double blind cryotherapy.
  • The sample size was small.
  • Results depended on assessment at completion of cycles, so some changes may have been missed. This study would have benefited from having additional, earlier assessment times.