Prophylaxis of Radiation-Associated Mucositis in Conventionally Treated Patients With Head and Neck Cancer: A Double-Blind, Phase III, Randomized, Controlled Trial Evaluating the Clinical Efficacy of an Antimicrobial Lozenge Using a Validated Mucositis Scoring System

Abstract

This study was conducted on the basis of a pilot study that demonstrated the BCoG lozenge to be tolerable and microbiologically efficacious. A validated mucositis scoring system was used. However, in this group of patients treated with conventional radiotherapy, the lozenge did not impact significantly on the severity of mucositis. Whether such a lozenge would be beneficial in treatment situations where rate of severe mucositis is higher (ie, in patients treated with unconventional fractionation or with concomitant chemotherapy) is unknown.

Systematic review of antimicrobials, mucosal coating agents, anesthetics, and analgesics for the management of oral mucositis in cancer patients

“…In addition, a well-controlled, multicenter, double-blind RCT examined the effect of a lozenge containing bacitracin, clotrimazole, and gentamicin (BCoG) for the prevention of radiation-induced OM in 137 H&N cancer patients. No difference was found in the extent of severe mucositis or in the time to development of severe mucositis [31]. The previously discussed body of evidence continued to support a recommendation against the use of these combined antimicrobial preparations for the prevention of OM.…”

Nutritional support for head and neck cancer patients receiving radiotherapy: a systematic review

“…Acute toxicities are exacerbated by the use of concurrent chemotherapy (CRT), which may additionally cause anorexia, nausea, and vomiting [3]. Futhermore, nutritional compromise may continue after treatment due to chronic xerostomia, dysphagia, and fibrosis [4].…”

Induction of Apoptosis Using Inhibitors of Lysophosphatidic Acid Acyltransferase-β and Anti-CD20 Monoclonal Antibodies for Treatment of Human Non-Hodgkin's Lymphomas

“…Moreover, because the most severe apoptotic abnormalities were present in the large intestine, the potential role of luminal bacteria or bacterial products should be evaluated. Prior studies using elective microbial decontamination has been effective in protecting against mucositis associated with radiation therapy in patients with solid tumors (34,35). We will also investigate the use of intraluminal antibiotics that change the gut flora as a tool to protect against colonic mucosal injury after LPAAT-h inhibitor administration.…”