Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT) regimens and by radiation to the head and neck. The purpose of this study is to determine the effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM) according to World Health Organization (WHO) criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
Tablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days
Duration of Ulcerative Oral Mucositis
All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to document the duration for those that developed recurrent ulcerative oral mucositis
Time frame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle
Number of Participants With Ulcerative Oral Mucositis
All randomized subjects were directly observed by trained evaluators for at least 10 consecutive days during the chemotherapy cycle to identify recurrence of ulcerative oral mucositis.
Time frame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle
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