CORTICOSTEROIDS AND RADIATION MUCOSITIS IN HEAD AND NECK-CANCER - A DOUBLE-BLIND PLACEBO-CONTROLLED RANDOMIZED TRIAL

Patients with head and neck cancer were randomized in a double-blind m anner to receive 40 mg/day prednisone (n = 32) or placebo (n = 34). Th e prescribed daily tumour dose was 1.6 Gy twice daily with an interfra ction interval of greater than or equal to 6 h. Treatment interruption s were at the discretion of the radiation oncologists. The primary stu dy end-point was the total duration of treatment. A mean 4.4 day reduc tion was observed in the total elapsed treatment duration for the pred nisone arm, 34.3 versus 29.9 days (P = 0 013), which paralleled a sign ificantly lower median total tumour and biologically effective dose (B ED) Gy(10) in this arm. A trend favouring shorter treatment interrupti ons in the prednisone ann was also found, but not a reduction in the i ntensity or duration of mucositis. (C) 1998 Elsevier Science ireland L td. All rights reserved.