title: A pilot study evaluating the safety and microbiologic efficacy of an economically viable antimicrobial lozenge in patients with head and neck cancer receiving radiation therapy.
abstract: BACKGROUND
  Mucositis occurs in almost all radiotherapy-treated head and neck cancer patients, in approximately 75% of patients receiving hematopoietic marrow transplantation, and in approximately 40% of all patients who receive chemotherapy. Mucositis is painful, may affect all oral functions, and is a dose- and rate-limiting toxicity of therapy for cancer. Radiation-associated mucositis (onset, intensity, and duration) has been shown in recent clinical trials to be modified by the use of antibacterial/antifungal lozenges.
  
  
  OBJECTIVE
  The aim of this collaborative two-center phase II study was to assess the toxicity and microbiologic efficacy of an economically viable antimicrobial lozenge in the management of patients receiving radiation therapy for head and neck cancer.
  
  
  METHODS
  Seventeen patients scheduled to receive radical or postoperative radiotherapy were provided with bacitracin, clotrimazole, and gentamicin (BCoG) lozenges (one lozenge dissolved in the mouth qid from day 1 of radiotherapy until completion). Ease of use and palatability of the lozenges, patients' symptoms (swallowing and pain), and quantitative and qualitative microbiologic evaluation of an oral rinse collection was conducted at least once weekly during radiation therapy.
  
  
  RESULTS
  No significant side effects were reported from the use of the lozenges. The lozenges were well tolerated at the beginning of treatment by all patients, with some minor difficulty associated with oral discomfort toward the end of the treatment. Microbiologic evaluation showed consistent elimination of yeast organisms in all patients. In four patients there was no growth of gram-negative bacilli on culture, whereas in two patients, fluctuating counts were seen, and one patient had increased counts. The remaining patients had significant reduction in the gram-negative bacilli counts.
  
  
  CONCLUSIONS
  This study demonstrated that the BCoG lozenge is tolerable and microbiologically efficacious, achieving elimination of Candida in all patients and reduction in gram-negative flora in most patients. A phase III study is underway to evaluate the clinical efficacy of this lozenge.
authors.affiliation: Department of Radiation Oncology, Ottawa Regional Cancer Centre, University of Ottawa, 503 Smyth Road, Ottawa, Ontario K1H 1C4 Canada. samy.elsayed@orcc.on.ca
authors.forename: Samy
authors.initials: S
authors.lastname: El-Sayed
authors.forename: Joel
authors.initials: J
authors.lastname: Epstein
authors.forename: Erin
authors.initials: E
authors.lastname: Minish
authors.forename: Patricia
authors.initials: P
authors.lastname: Burns
authors.forename: John
authors.initials: J
authors.lastname: Hay
authors.forename: Ethan
authors.initials: E
authors.lastname: Laukkanen
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001414:Bacitracin / Q000008:administration & dosage* / Q000191:economics; D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy* / Q000601:surgery; D003022:Clotrimazole / Q000008:administration & dosage* / Q000191:economics; D005260:Female; D005500:Follow-Up Studies; D005839:Gentamicins / Q000008:administration & dosage* / Q000191:economics; D006258:Head and Neck Neoplasms / Q000532:radiotherapy* / Q000601:surgery; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000382:microbiology; D010865:Pilot Projects; D011829:Radiation Dosage; D011832:Radiation Injuries / Q000188:drug therapy*; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D013280:Stomatitis / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D005839:Gentamicins; D001414:Bacitracin; D003022:Clotrimazole