Tampere Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Department of Ear and Oral Diseases, Tampere University Hospital, Tampere, Finland.
Pediatr Blood Cancer. 2020 Oct;67(10):e28520. doi: 10.1002/pbc.28520. Epub 2020 Jul 29.
Oral mucositis (OM) is a significant side effect of cancer treatment. The purpose of this study was to compare topically administered Caphosol to saline rinses in the prevention of mucositis in pediatric cancer patients.
A controlled, double-blinded, and randomized clinical crossover study recruited patients between 2 to 17.99 years of age who were diagnosed with a malignancy and were receiving either high-dose methotrexate (≥1 g/m ), anthracycline, or cisplatin chemotherapy (NCT0280733). All patients received two 7-day cycles of the mouth rinses; that is, one cycle of Caphosol and one cycle of saline in a randomized order. Oral changes and symptoms were evaluated using the World Health Organisation (WHO) toxicity scale and the Children's International Mucositis Evaluation Scale (ChIMES). The primary endpoint was the frequency and severity of OM and oral symptoms.
A total of 56 patients were recruited to the study, of whom 45 were randomized with a median age of 6.5 years (range 2.1-17.1 years). No cases of severe OM were observed. Grade ≥ 3 oral symptoms were present at least once in six (13%) patients during the Caphosol cycle and 13 (29%) patients during the saline cycle (P = .12). The peak of symptom scores was evident at around day 4-7 after administration of the chemotherapy with no marked differences between the rinse solutions. Multivariable regression analysis did not indicate a benefit of using Caphosol over the saline solution.
No difference in prevention of oral mucositis was observed between the use of Caphosol or saline rinses.
口腔黏膜炎（OM）是癌症治疗的一种严重副作用。本研究旨在比较局部给予 Caphosol 与生理盐水冲洗在预防儿科癌症患者黏膜炎方面的效果。
一项对照、双盲、随机交叉临床试验招募了年龄在 2 至 17.99 岁之间、被诊断患有恶性肿瘤且正在接受高剂量甲氨蝶呤（≥1 g/m²）、蒽环类药物或顺铂化疗的患者（NCT0280733）。所有患者均接受了两个为期 7 天的漱口周期；即，以随机顺序接受 Caphosol 一个周期和生理盐水一个周期。采用世界卫生组织（WHO）毒性量表和儿童国际黏膜炎评估量表（ChIMES）评估口腔变化和症状。主要终点是 OM 和口腔症状的频率和严重程度。
共招募了 56 名患者进行研究，其中 45 名患者被随机分组，中位年龄为 6.5 岁（范围 2.1-17.1 岁）。未观察到严重的 OM 病例。在 Caphosol 周期中，至少有 6 名（13%）患者出现了≥3 级口腔症状，而在生理盐水周期中，有 13 名（29%）患者出现了这种症状（P=0.12）。在给予化疗后约 4-7 天，症状评分达到峰值，两种漱口液之间没有明显差异。多变量回归分析并未表明使用 Caphosol 优于生理盐水溶液。
在预防口腔黏膜炎方面，使用 Caphosol 或生理盐水冲洗没有差异。
