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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.
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.