Purpose: The aim of the study was to test the hypothesis that aerobic Gram-negative bacteria (AGNB) play a crucial role in the pathogenesis of radiation-induced mucositis; consequently, selective elimination of these bacteria from the oral flora should result in a reduction of the mucositis. Methods and Materials: Head-and-neck cancer patients, when scheduled for treatment by external beam radiation therapy (EBRT), were randomized for prophylactic treatment with an oral paste containing either a placebo or a combination of the antibiotics polymyxin E, tobramycin, and amphotericin B (PTA group). Weekly, the objective and subjective mucositis scores and microbiologic counts of the oral flora were noted. The primary study endpoint was the mucositis grade after 3 weeks of EBRT. Results: Seventy-seven patients were evaluable. No statistically significant difference for the objective and subjective mucositis scores was observed between the two study arms (p = 0.33). The percentage of patients with positive cultures of AGNB was significantly reduced in the PTA group (p = 0.01). However, complete eradication of AGNB was not achieved.Conclusions: Selective elimination of AGNB of the oral flora did not result in a reduction of radiation-induced mucositis and therefore does not support the hypothesis that these bacteria play a crucial role in the pathogenesis of mucositis. Copyright

Antibiotics, Head-and-neck tumors, Mucositis, Oral flora, Radiation therapy
dx.doi.org/10.1016/S0360-3016(01)01444-4, hdl.handle.net/1765/62923
International Journal of Radiation: Oncology - Biology - Physics
Department of Pharmacy

Wijers, O.B, Levendag, P.C, Harms, E.R.E, Gan-Teng, A.M, Schmitz, P.I.M, Hendriks, W, … Visch, I. (2001). Mucositis reduction by selective elimination of oral flora in irradiated cancers of the head and neck: A placebo-controlled double-blind randomized study. International Journal of Radiation: Oncology - Biology - Physics, 50(2), 343–352. doi:10.1016/S0360-3016(01)01444-4