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Study protocol for efficacy and safety of steroid-containing mouthwash to prevent chemotherapy-induced stomatitis in women with breast cancer: a multicentre, open-label, randomised phase 2 study.
Kuba, S, Yamanouchi, K, Matsumoto, M, Maeda, S, Hatachi, T, Sakiko, S, Kawashita, Y, Morita, M, Sakimura, C, Inamasu, E, et al
BMJ open. 2020;(2):e033446
Abstract
INTRODUCTION Stomatitis is a frequent adverse event in patients undergoing chemotherapy for breast cancer. Stomatitis can hamper oral nutrition resulting in malnutrition, reduce quality of life and introduce the need for dose reductions and interruption of chemotherapy; however, there is currently no standard approach for preventing chemotherapy-induced stomatitis. We aimed to assess the safety and efficacy of a dexamethasone-based elixir mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer. METHODS AND ANALYSIS In this multicenter, randomised, controlled phase 2 trial, we will randomly assign 120 women with early breast cancer undergoing chemotherapy to use of a dexamethasone-based elixir or standard oral care, to compare their preventive effects on chemotherapy-induced stomatitis. Patients will be assigned in a 1:1 ratio. Patients in the intervention group will receive chemotherapy, oral care and a dexamethasone-based elixir (10 mL 0.1 mg/mL; swish for 2 min and spit, four times daily for 9 weeks), and patients in the control group will receive chemotherapy and oral care. The primary endpoint is the difference in incidence of stomatitis between the two groups. The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups. Secondary endpoints are severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events. ETHICS AND DISSEMINATION All participants signed a written consent form, and the study protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University (CRB7180001). TRIAL REGISTRATION NUMBER UMIN Clinical Trials Registry (UMIN000030489).
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Efficacy of a New Post-Mouthwash Intervention (Wiping Plus Oral Nutritional Supplements) for Preventing Aspiration Pneumonia in Elderly People: A Multicenter, Randomized, Comparative Trial.
Higashiguchi, T, Ohara, H, Kamakura, Y, Kikutani, T, Kuzuya, M, Enoki, H, Sanada, H, Matsuzaki, M, Maruyama, M
Annals of nutrition & metabolism. 2017;(3-4):253-260
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Abstract
BACKGROUND/AIMS: Aspiration pneumonia is a common cause of death among the elderly (≥90-year-old) in nursing homes. Studies suggest that its incidence could be reduced by oral care interventions. We aimed to evaluate the efficacy of a new oral care intervention: wiping plus oral nutritional supplements (ONS). METHODS This prospective observational study was conducted in 252 patients (age 88.0 ± 6.5 years) in 75 nursing homes, rehabilitation hospitals, and other care facilities. Patients were randomly divided into an intervention group (n = 74) and a control group (n = 107), whose members received conventional oral care. Body mass index, activities of daily living (Barthel index), and complete blood count and biochemistry parameters were measured at 2, 4, 6, and 8 months. RESULTS The cumulative incidence of pneumonia at 8 months tended to be lower in the intervention than in the control group (7.8 vs. 17.7%, p = 0.056) and was significantly lower for men in the intervention group (p = 0.046). CONCLUSIONS Our new intervention "wiping plus providing ONS" method appears to help prevent aspiration pneumonia, thereby reducing mortality risk. In this study, we disseminate information on how this method is used in Japan.
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Caphosol, a therapeutic option in case of cancer therapy-induced oral mucositis in children? : Results from a prospective multicenter double blind randomized controlled trial.
Raphael, MF, den Boer, AM, Kollen, WJ, Mekelenkamp, H, Abbink, FC, Kaspers, GJ, Zomer-Kooijker, K, Molmans, BH, Tissing, WJ
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2014;(1):3-6
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Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis: a phase-2 multi-center study.
Van Dyke, T, Paquette, D, Grossi, S, Braman, V, Massaro, J, D'Agostino, R, Dibart, S, Friden, P
Journal of clinical periodontology. 2002;(2):168-76
Abstract
OBJECTIVE P-113, a 12 amino acid histatin-based peptide, was evaluated in a mouthrinse formulation for safety and efficacy in a phase 2 multi-center clinical study. METHOD 294 healthy subjects abstained from oral hygiene procedures and self-administered either 0.01% P-113, 0.03% P-113 or placebo mouthrinse formulations twice daily over a 4-week treatment period. During this time, the safety, anti-gingivitis, and anti-plaque effects of P-113 were evaluated. RESULTS There was a significant reduction in the change from baseline to Day 22 in bleeding on probing in the 0.01% P-113 treatment group of the intent to treat population (p=0.049). Non-significant trends in the reduction of the other parameters were observed in this population (p> or =0.159). A sub-group of subjects which developed significant levels of disease within the four-week timeframe of the study was identified based on baseline gingival index scores > or =0.75. Significant findings were observed for bleeding on probing, gingival index and plaque index within this population (p<0.05). There were no treatment-related adverse events, and there were no adverse shifts in supragingival microflora during the study. Significant amounts of the peptide were retained in the oral cavity following rinsing. CONCLUSION These data suggest that P-113 mouthrinse is safe and reduces the development of gingival bleeding, gingivitis and plaque in the human experimental gingivitis model.