Dazzi, C., Cariello, A., Giovanis, P., Monti, M., Vertogen, B., Leoni, M. … Marangolo, M. (2003). Prophylaxis with GM-CSF mouthwashes does not reduce frequency and duration of severe oral mucositis in patients with solid tumors undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue: A double blind, randomized, placebo-controlled study. Annals of Oncology, 14, 559–563.doi: 10.1093/annonc/mdg177
Patients were stratified on the basis of their conditioning treatment. Patients in the treatment group were given granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwash, 150 mcg per day in 100 cm3 of sterile water. Patients in the control group received 100 cm3 of sterile water alone as placebo. Both groups were instructed to perform one-minute mouthwashes, four times per day. Treatment started the day after chemotherapy ended and continued until stomatitis resolution, neutrophil recovery, or both.
The study was conducted between July 1997 and February 2002.
This was a double-blind, randomized, placebo-controlled study.
The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) for mucositis was used.
The intervention was not effective.