TREATMENT OF RADIOGENIC MUCOSITIS IN PATI ENTS WITH HEAD AND NECK TUMORS WITH POLYVALENT INTRAMUSCULAR IMMUNOGLOBULIN

In a randomized, double-blind study 81 patients suffering from radioge nic mucositis during radiotherapie of head and neck cancer were treate d with polyvalent intramuscular immunoglobulin versus placebo. Study e ntry requirements were EORTC grade 1 or 2 mucositis. The treatment reg ime was 10 mL on day 0 and 5 mL on day 2 and 4, respectively. On day 7 in the verum group 79% of the patients had a reduction to grade 1 (re adness) or 0 (inconspicuous) compared to 44% in the placebo group. Thi s difference was highly significant (p < 0.01). Similar benefits with the immunoglobulin therapy was obtained in the treatment of edemas, dy sphagia, throataches but not in dermatitis, perichondritis, oral candi dosis, and xerostomia. After termination of the double-blind part immu noglobuline was available for all patients and proved to be beneficial for the initial placebo group as well. Local or systemical side-effec ts during the course of the study have not been observed.