A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSSOVER TRIAL OF PENTOXIFYLLINE FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED ORAL MUCOSITIS

Oral mucositis is a frequent side effect of cancer therapy. No effective method of prophylaxis is currently available, We conducted a randomized, double-blind, placebo-controlled, crossover trial of pentoxifylline to evaluate its potential in preventing mucositis in cancer patients receiving chemotherapy. Ten cancer patients were randomized for treatment with a 15-day course of 400 mg of pentoxifylline given orally four times daily. Concurrent chemotherapy consisted of bolus cisplatin and infusional 5-fluorouracil. Mucositis was evaluated with the use of the Oral Assessment Guide developed at the University of Nebraska. Patients completing two cycles of chemotherapy-one with pentoxifylline and one with placebo-were evaluated for prophylaxis efficacy. Comparison of the oral assessment scores of the two cycles with a two-sided Student's t test failed to demonstrate a cytoprotective effect for pentoxifylline over placebo. We conclude thai pentoxifylline as given in this study is ineffective for preventing mucositis in patients receiving cisplatin and 5-FU.