CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
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The risk factors for oral mucositis and the effect of cryotherapy in patients after the BEAM and HD-l-PAM 200 mg/m(2) autologous hematopoietic stem cell transplantation.

PURPOSE: Oral mucositis (OM) still represents a significant complication of hematopoietic stem cell transplantations (HSCT). Observational studies focusing on risk factor definitions are still warranted.

METHOD: A total of 126 patients participated in this observational study after autologous HSCT with the BEAM and HD-l-PAM 200mg/m(2) conditioning regimens. Basic clinical and laboratory variables and their impact on OM were assessed.

RESULTS: Age, gender, body mass index, and baseline absolute neutrophil counts were not shown to have any negative impact on OM development. The multivariate analysis revealed oral cryotherapy non-provision as being the most significant predictor for OM incidence (p < 0.0001), followed by BEAM conditioning regimen (p = 0.007), OM in a patient's history (p = 0.002) and lower number of days since the last chemotherapy (p = 0.025). The cryotherapy was remarkably effective both in the single high-dose melphalan 200mg/m(2) conditioning regimen (18% OM in cryotherapy vs. 68% without it, p<0.0001) and in the multidrug BEAM (melphalan 140mg/m(2)) regimen (38% vs. 86%, p=0.006).

CONCLUSION: Oral cryotherapy should be implemented into supportive care management in patients treated with high-dose melphalan short-infusion chemotherapy. Large and well-designed randomized trials are necessary to obtain more significant and reliable results and understanding regarding OM risk factors.

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