We conducted a double-blind, placebo-controlled, randomized trial to evaluate the efficacy and safety of
tetrachlorodecaoxide (
TCDO) in patients with
chemotherapy-induced
mucositis. Sixty-two patients with World Health Organization grade II-IV
oral mucositis were eligible for the study. They were randomized to receive
TCDO or placebo, 10 ml, twice daily, swish and swallow, for 7 days. Patients were evaluated for oral
pain,
dysphagia, and oral intake. Downgrading and total duration of
mucositis were documented. Thirty-two were randomized to receive
TCDO. Thirty received the placebo. All were evaluable. Both arms were well matched for age, gender, type of underlying
neoplasm, and prior history of
oral mucositis. Intensity of initial symptoms, degree of
mucositis, and time period between delivery of
chemotherapy and development of
mucositis were also similar. Post-
therapy evaluation revealed no significant difference in the mean grade of oral and esophageal
pain, or
dysphagia between
TCDO and placebo. Downgrading or total duration of
mucositis did not differ between the two groups. Oral intake improved significantly in patients taking
TCDO. Time to subjective improvement in oral
pain was significantly shorter with
TCDO (3.1 versus 3.6 days). Evaluation on day 3 revealed that 77% of those receiving
TCDO were free of oral
pain in comparison to 46% receiving placebo (P = 0.05). These results indicate that
TCDO may be helpful in palliating some of the symptoms related to
oral mucositis. The therapeutic benefit, however, is small and needs to be confirmed in a larger trial.