Oral mucositis and selective elimination of oral flora in head and neck cancer patients receiving radiotherapy: a double-blind randomised clinical trial

Mucositis is an acute inflammation of the oral mucosa because of radiotherapy and/or chemotherapy. All patients receiving radiotherapy in the head and neck region develop oral mucositis. The aim of this study was to analyse the effects of selective oral flora elimination on radiotherapy-induced oral mucositis, in a double-blind, randomised, placebo-controlled trial. Sixty-five patients with a malignant tumour in the head and neck regions to be treated with primary curative or postoperative radiotherapy participated in this study. The patients received either the active lozenges of 1 g containing polymyxin E 2 mg, tobramycin 1.8 mg and amphotericin B 10 mg (PTA) (33 patients) or the placebo lozenges (32 patients), four times daily during the full course of radiotherapy. Mucositis, changes in the oral flora, quality of feeding and changes of total body weight were assessed. Mucositis score did not differ between the groups during the first 5 weeks of radiotherapy. Nasogastric tube feeding was needed in six patients (19%) of the placebo group and two patients (6%) of the PTA group (P=0.08). Mean weight loss after 5 weeks of radiation was less in the PTA group (1.3 kg) (s.d.: 3.0) than in the placebo group (2.8 kg) (s.d.: 2.9) (P=0.05). Colonisation index of Candida species and Gram-negative bacilli was reduced in the PTA group and not in the placebo group (P<0.05). No effect on other microorganisms was detected. In conclusion, selective oral flora elimination in head and neck irradiation patients does not prevent the development of severe mucositis. Record 8 of 10 - SilverPlatter MEDLINE(R)

Efeito da clorexidina na mucosite induzida por radioterapia em câncer de cabeça e pescoço Effects of chlorhexidine mouthwash on radiation induced mucosistis in head and neck cancer

A radioterapia em pacientes com neoplasias de Cabeça e Pescoço causa alterações na mucosa oral comprometendo a execução terapêutica e o resultado final. OBJETIVO: Avaliar o efeito protetor do gluconato de clorexidina, sobre a mucosa oral, durante o tratamento actínico fracionado e o seu reflexo na qualidade de vida referida pelos pacientes. FORMA DE ESTUDO: Clínico prospectivo. MATERIAL E MÉTODO: Foram selecionados 21 portadores de câncer de Cabeça e Pescoço alocados em dois grupos: grupo Placebo (n=11, 9H e 2M, idade média 58 anos) água destilada - dois bochechos diários e grupo Medicação (n=10, 7H e 2M, idade média 52 anos) gluconato de clorexidina a 0,12% - dois bochechos diários. Os pacientes foram avaliados semanalmente com exame local para detecção das alterações de mucosa (classificação de acordo com a WHO e Grupo de Terapia por Radiação em Oncologia - graus 0 a IV) e preenchimento de questionário de qualidade de vida ressaltando os aspectos de dor, apetite, paladar e hábitos alimentares. A análise estatística realizada pelo teste exato de Fisher. RESULTADOS: A graduação da mucosite foi mais intensa no grupo Placebo em 6 das 10 semanas de avaliação. A freqüência e intensidade das dores foram piores no grupo Placebo na 4ª semana de radioterapia e a modificação de paladar foi mais intensa nos indivíduos que não usavam o medicamento apenas na 7ª semana. Não foram encontradas diferenças nos outros parâmetros de qualidade de vida. CONCLUSÃO: Podemos concluir que o gluconato de clorexidina não eliminou as lesões de mucosa mas diminuiu, significativamente, os seus efeitos deletérios e intensidade sem apresentar um reflexo persistente na qualidade de vida dos pacientes.<br>The radiotherapy in patients with neoplasias of Head and Neck causes alterations in the oral mucous membrane interfering with the therapeutic execution and the final result. AIM: To evaluate the protective effect of the chlorhexidin on the oral mucous membrane, during the radiotherapy and its reflex in the quality of life referred by patients. STUDY DESIGN: Clinical prospective. MATERIAL AND MATHOD: 21 patients with cancer of Head and Neck were selected and allocated in two groups: group Placebo (n=11, 9 men and 2 women, mean age 58 years) distilled water - two daily mouthwashes and group Medication (n=10, 7 men and 2 women, mean age 52 years) chlorhexidin 0,12% - two daily mouthwashes. The patients were appraised weekly with local exam for detection of the mucous membrane alterations (classification in agreement with WHO and Group of Therapy for Radiation in Oncology - degrees 0 to IV) and completion of questionnaire of life quality emphasizing the pain aspects, appetite, palate and alimentary habits. The statistical analysis accomplished by Fisher's exact test. RESULTS: The graduation of mucositis was more intense in the group Placebo in 6 of the 10 weeks of evaluation. The frequency and intensity of pain were worse in the group Placebo in the 4th week of radiotherapy and the palate modification was more intense in the individuals that didn't use the medicine just in the 7th week. They were not found differences in the other parameters of life quality. CONCLUSIONS: We can conclude that the chlorhexidin didn't eliminate the mucous membrane lesions but decreased, significantly, their harmful effects and intensity without presenting a persistent reflex in the quality of the patients' life