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McAleese, J.J., Bishop, K.M., A’Hern, R., & Henk, J.M. (2006). Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer. British Journal of Radiology, 79(943), 608–613.
Intervention Characteristics/Basic Study Process
GM-CSF 2 mcg/kg (-1) (150 mcg) daily for 14 days starting on day 14 of a 21-day course of RT.
Note: Placebo injections were not given; observer was blinded to treatment.
Sample Characteristics
The study was comprised of 29 patients (GM-CSF = 14).
Power analysis was completed, but not met (n = 17 in each group).
Patients with proven T1 N0 or T2 N0 glottic carcinoma were being treated with radiotherapy using a 16 fraction 3-week regimen.
Required to have a WHO performance status of grade 0 or higher, no renal or hepatic issues, serious infections requiring antibiotics, or likely need for corticosteroids.
Study Design
Prospective, randomized, observer blind phase II trial
Measurement Instruments/Methods
RTOG
Skin erythema
Moist and dry desquamation
Pain on swallowing
Severity of dysphagia
Analgesic usage
Evidence of candida infection and laryngeal edema
Patients weights before and after treatment
Results
Significant difference in the incidence of mucositis p < 0.05, mean time of healing improved but not significant p = 0.25.
No differences in dysphagia, odynophagia, analgesic use, candida infection, of laryngeal edema.
Limitations
Study sample size was very small.
Only used for early treatment of laryngeal cancer with radiotherapy using 16 fraction 3-week regimen.