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 manner to receive 40 mg/day prednisone (n = 32) or placebo (n = 34). The prescribed daily tumour dose was 1.6 Gy twice daily with an interfraction interval of > or =6 h. Treatment interruptions were at the discretion of the radiation oncologists. The primary study end-point was the total duration of treatment. A mean 4.4 day reduction was observed in the total elapsed treatment duration for the prednisone arm, 34.3 versus 29.9 days (P = 0.013), which paralleled a significantly lower median total tumour and biologically effective dose (BED) Gy10 in this arm. A trend favouring shorter treatment interruptions in the prednisone arm was also found, but not a reduction in the intensity or duration of mucositis.
Department of Radiation Oncology, Instituto de Radiología y Centro de Lucha contra el Cáncer, Hospital Pereira Rossell, Montevideo, Uruguay.
J H
JH
Leborgne
F
F
Leborgne
E
E
Zubizarreta
B
B
Ortega
J
J
Mezzera
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy*; D019583:Dose Fractionation, Radiation; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009092:Mucous Membrane / Q000528:radiation effects*; D011241:Prednisone / Q000627:therapeutic use*; D011832:Radiation Injuries / Q000517:prevention & control*; D011879:Radiotherapy Dosage
D005938:Glucocorticoids; D011241:Prednisone