Hejna, M., Kostler, W.J., Raderer, M., Steger, G.G., Brodowicz, T., Scheithauer, W., … Zielinski, C.C. (2001). Decrease of duration and symptoms in chemotherapy-induced oral mucositis by topical GM-CSF: Results of a prospective randomized trial. European Journal of Cancer, 37, 1971–1975.
Patients were randomized to one of two arms.
Both groups were instructed to continue using the respective mouthwashes until complete response (CR). A third, independent investigator randomized patients without knowing individual mucositis ratings.
The study was conducted between March 1998 and June 1999.
This was a prospective, randomized, controlled study.
Every three days, objective and subjective evaluations were conducted.