Sandra Cabrera-Jaime1, Cristina Martínez2, Tarsila Ferro-García3, Pilar Giner-Boya4, Teresa Icart-Isern5, Joan M Estrada-Masllorens5, Paz Fernández-Ortega6. 1. Nursing Research, Catalan Institute of Oncology (ICO), L'Hospitalet de Llobregat, Barcelona, Spain; GRIN Group, IDIBELL, Institute of Biomedical Research, University of Barcelona, Nursing School, Campus of Health Sciences, L'Hospitalet de Llobregat, Barcelona, Spain. 2. Tobacco Control Unit, Cancer Control and Prevention Programme, Catalan Institute of Oncology (ICO), L'Hospitalet de Llobregat, Barcelona, Spain; Cancer Control and Prevention Group, Institut d'Investigació Biomèdica de Bellvitge-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain; Nursing Departament, School of Medicine and Health Sciences, Universitat Internacional de Catalunya, Sant Cugat del Valles, Barcelona, Spain. Electronic address: cmartinez@iconcologia.net. 3. GRIN Group, IDIBELL, Institute of Biomedical Research, University of Barcelona, Nursing School, Campus of Health Sciences, L'Hospitalet de Llobregat, Barcelona, Spain; Director of Nursing, Catalan Institute of Oncology (ICO), L'Hospitalet de Llobregat, Barcelona, Spain. 4. Pharmacy Departament, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain. 5. GRIN Group, IDIBELL, Institute of Biomedical Research, University of Barcelona, Nursing School, Campus of Health Sciences, L'Hospitalet de Llobregat, Barcelona, Spain. 6. Nursing Research, Catalan Institute of Oncology (ICO), L'Hospitalet de Llobregat, Barcelona, Spain.
Abstract
PURPOSE:Oral mucositis is one of the most common adverse effects of chemotherapy and radiotherapy. The aim of this study was to compare the efficacy of Plantago major extract versus chlorhexidine 0.12% versus sodium bicarbonate 5% in the symptomatic treatment of chemotherapy-induced oral mucositis in solid tumour cancer patients. METHOD: Multicentre randomised controlled trial estimated sample of 45 solid tumour patients with grade II-III mucositis. The participants were randomised to one of three treatments, consisting of sodium bicarbonate 5% aqueous solution together with: an additional dose of sodium bicarbonate 5% aqueous solution, Plantago major extract, or chlorhexidine 0.12%. The primary outcomes were severity of mucositis, pain intensity, oral intake capacity and quality of life. The independent variable was treatment group, and confounders included sociodemographic data, neutrophil count, chemotherapy drug and dose received. RESULTS: Of the 50 patients enrolled, 68% (n = 34) achieved grade 0 mucositis (none), with those using the double sodium bicarbonate rinse healing in five days on average (95% CI 3.9, 6.5) versus seven days (95% CI 5.3, 9,0) for the chlorhexidine group and seven days (95% CI 5.3, 8.5) for the Plantago major group. The pain experienced by the participants lessened over the 14 days of treatment, but differences in pain intensity between the three groups did not show statistical significance (p = 0.762). CONCLUSIONS:Healing time was shorter with the double sodium bicarbonate solution compared to the other two rinses, but the differences were not significant. Our results suggest it may be time to reconsider the use of Plantago major extract in the management of oral mucositis.
RCT Entities:
PURPOSE:Oral mucositis is one of the most common adverse effects of chemotherapy and radiotherapy. The aim of this study was to compare the efficacy of Plantago major extract versus chlorhexidine 0.12% versus sodium bicarbonate 5% in the symptomatic treatment of chemotherapy-induced oral mucositis in solid tumour cancerpatients. METHOD: Multicentre randomised controlled trial estimated sample of 45 solid tumourpatients with grade II-III mucositis. The participants were randomised to one of three treatments, consisting of sodium bicarbonate 5% aqueous solution together with: an additional dose of sodium bicarbonate 5% aqueous solution, Plantago major extract, or chlorhexidine 0.12%. The primary outcomes were severity of mucositis, pain intensity, oral intake capacity and quality of life. The independent variable was treatment group, and confounders included sociodemographic data, neutrophil count, chemotherapy drug and dose received. RESULTS: Of the 50 patients enrolled, 68% (n = 34) achieved grade 0 mucositis (none), with those using the double sodium bicarbonate rinse healing in five days on average (95% CI 3.9, 6.5) versus seven days (95% CI 5.3, 9,0) for the chlorhexidine group and seven days (95% CI 5.3, 8.5) for the Plantago major group. The pain experienced by the participants lessened over the 14 days of treatment, but differences in pain intensity between the three groups did not show statistical significance (p = 0.762). CONCLUSIONS: Healing time was shorter with the double sodium bicarbonate solution compared to the other two rinses, but the differences were not significant. Our results suggest it may be time to reconsider the use of Plantago major extract in the management of oral mucositis.
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