Sprinzl, G.M., Glava, O., deVries, A., Ulmer, H., Gunkel, A.R., Lukas, P., et al. (2001). Local application of granulocyte-macrophage colony stimulating factor (GM_CSF) for the treatment of oral mucositis. European Journal of Cancer, 37, 2003-2009.
GM-CSF topically (Leukomax mouthwash)
Given in 250 ml 400 mcg recombinant Escherichia coli GMCSF once daily as soon as erythema was diagnosed, ordered to swish and swallow over period of 1 hr.
Control arm – conventional mouthwash (Hydrocortisone, Pantocain)
Patients also told to maintain strict oral hygiene using a soft toothbrush and fluoride toothpaste, and to avoid tobacco, alcoholic beverages, very hot and cold food, and spicy food.
Stratified for RT chem. Combination or RT alone.
All patients had daily rinses at least 3x/day. GM-CSF versus pantocain, hydrocortisone, cional kreussler, and bepathen (European product).
The study was comprised of 59 patients, recruited, 14 not randomized, patients = 45.
GMCSF group = 23, 21 control
18 and 17 completed trial
Jan 1997 – Oct 1998
Prospective, randomized, parallel grouped phase II clinical trial (non-blinded)
WHO scale for mucositis
No statistically significant evidence was reached in the grade of oral mucositis or the patient’s perception of oral pain.
Unable to determine therapeutic benefit of control arm product versus lack of effect of GM-CSF versus benefit of strict oral hygiene.
Authors conclude the agent cannot be recommended.
Intervention not effective