MISOPROSTOL PROPHYLAXIS FOR HIGH-DOSE CHEMOTHERAPY-INDUCED MUCOSITIS - A RANDOMIZED DOUBLE-BLIND-STUDY

From April 1993 to September 1993, 15 patients with lymphoid or solid neoplasms underwent 16 non-cryopreserved peripheral stem cell transpla ntation courses using the ICE (ifosfamide, carboplatin, etoposide) pro gram, They were randomized in a double-blind clinical trial to receive oral misoprostol or placebo for mucositis prophylaxis. The active dru g or placebo administration began jointly with chemotherapy at day -4 and was continued until day 16, The mucositis incidence and severity w as significantly higher in patients who received misoprostol, We found no differences regarding myelosuppression, infections or other chemot herapy complications. Our results do not support the use of oral misop rostol as administered in this study, for high-dose chemotherapy-induc ed mucositis prophylaxis.