Walladbegi Java, Svanberg Anncarin, Gellerstedt Martin
Department of Oral Medicine and Pathology, Institute of Odontology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Hematology, Faculty of Medicine, Institute for Medical Sciences, Uppsala University Hospital, Uppsala, Sweden.
BMJ Open. 2018 Oct 24;8(10):e021993. doi: 10.1136/bmjopen-2018-021993.
A majority of patients who receive myeloablative therapy prior to hematopoetic stem cell transplantation develop oral mucositis (OM). This adverse cytotoxic effect manifests as oral mucosal erythema and ulcerations and frequently necessitates high doses of morphine for pain alleviation. OM may also interfere with food intake and result in parenteral nutrition, weight loss and impaired quality of life. To date, there have been a few studies of evidence-based interventions for prevention of OM. Cooling the oral mucosa using ice chips in conjunction with chemotherapy is known to reduce the severity of OM although clinical application is still limited due to several disadvantages. The primary endpoint of this study is therefore to evaluate the efficacy of an innovative intraoral cooling device (Cooral) compared with ice cooling in reducing the degree of OM, in patients with myeloma or lymphoma.
A total of 180 patients from four different university hospitals in Sweden will be randomised to ice or Cooral in a proportion of 1:1. The degree of OM will be assessed at eight intraoral locations, in accordance with the Oral Mucositis Assessment Scale and WHO scale. Patients will be registered beginning at admission and will continue until discharge or until day +28. The primary variable is analysed in a multiple linear regression model. The significance level used is 5%.
The study protocol, questionnaire, diaries and letter of invitation to participants have been reviewed by the local ethical board in Göteborg. The trial results will be published in a peer-reviewed journal and disseminated to participants.
NCT03203733; Pre-results.
Version 4, 2017-06-05.
大多数在造血干细胞移植前接受清髓治疗的患者会发生口腔黏膜炎（OM）。这种不良的细胞毒性作用表现为口腔黏膜红斑和溃疡，常常需要大剂量吗啡来缓解疼痛。OM还可能干扰食物摄入，导致肠外营养、体重减轻和生活质量受损。迄今为止，关于预防OM的循证干预措施的研究较少。已知在化疗期间使用冰片冷却口腔黏膜可降低OM的严重程度，不过由于存在一些缺点，其临床应用仍然有限。因此，本研究的主要终点是评估一种创新的口腔内冷却装置（Cooral）与冰敷相比，在降低骨髓瘤或淋巴瘤患者OM程度方面的疗效。
来自瑞典四家不同大学医院的总共180名患者将按1:1的比例随机分为接受冰敷组或Cooral组。将根据口腔黏膜炎评估量表和世界卫生组织量表在口腔内的八个部位评估OM的程度。患者将从入院开始登记，持续至出院或直至第+28天。主要变量在多元线性回归模型中进行分析。使用的显著性水平为5%。
研究方案、问卷、日记以及给参与者的邀请函已由哥德堡当地伦理委员会审查。试验结果将发表在同行评审期刊上并传达给参与者。
NCT03203733；预结果。
第4版，2017年6月5日。
