A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT. Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
10
Policlinico Universitario "A. GEMELLI"
Rome, Rome, Italy
RECRUITINGCOMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
Time frame: days -14;-7; 0;+7;+14;+21
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM
Time frame: days -14;-7; 0; +7;+14; +21
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