A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL TO EVALUATE THE ROLE OF TETRACHLORODECAOXIDE IN THE MANAGEMENT OF CHEMOTHERAPY-INDUCEDORAL MUCOSITIS

We conducted a double-blind, placebo-controlled, randomized trial to e valuate the efficacy and safety of tetrachlorodecaoxide (TCDO) in pati ents with chemotherapy-induced muscositis. Sixty-two patients with Wor ld Health Organization grade II-IV oral mucositis were eligible for th e study. They were randomized to receive TCDO or placebo, 10 mt twice daily, swish and swallow, for 7 days. Patients were evaluated for oral pain, dysphagia, and oral intake. Downgrading and total duration of m ucositis were documented. Thirty-two were randomized to receive TCDO. Thirty received the placebo. All were evaluable. Both arms were well m atched 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 signif icant difference in the mean grade of oral and esophageal pain, or dys phagia between TCDO and placebo. Downgrading or total duration of muco sitis did not differ between the two groups. Oral intake improved sign ificantly in patients taking TCDO. Time to subjective improvement in o ral pain was significantly shorter with TCDO (3.1 versus 3.6 days). Ev aluation 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 sy mptoms related to oral mucositis. The therapeutic benefit, however, is small and needs to be confirmed in a larger trial. (C) U.S. Cancer Pa in Relief Committee, 1997.