RCT of an Herbal Mouthrinse for Radiotherapy Induced Mucositis in Cancer Patients

描述（由申请人提供）：我们研究的广泛目标是开发有效的补充和替代医学（CAM）方法，以预防粘膜炎或减轻其严重程度和并发症。口腔粘膜炎（OM）是传统放疗（RT）的一种临床挑战性和使人衰弱的副作用，几乎影响所有接受RT治疗的头颈部癌症患者。OM包括伴有或不伴有机会性微生物感染的口腔粘膜炎症。它的范围从轻度红斑到严重溃疡，伴有持续疼痛，导致无法耐受或吞咽食物和液体。OM经常导致不必要的癌症治疗剂量减少或治疗中断。尽管使用了止痛药，但严重的OM与昂贵的医疗保健资源的使用大幅增加有关。目前还没有有效的治疗方法。本提案的主要目的是确定含有具有已知抗炎和抗微生物药物特性的草药提取物的漱口水是否会降低接受头颈部常规放疗的癌症患者口腔粘膜炎的严重程度。由于OM突出的炎症和微生物方面，我们预计草药漱口水将减少与OM相关的疼痛和继发性感染的严重程度，并将改善接受RT的头颈癌患者的生活质量。因此，我们的II期双盲、随机、对照试验是1）确定与接受对照漱口水的患者相比，接受草药漱口水的RT患者口腔粘膜炎的严重程度是否降低，以及2）以确定草药漱口水对口腔微生物环境和生活质量的影响。这项研究的结果将提供证据，支持对草药提取物减少口腔粘膜炎的抗炎和抗微生物机制进行更深入的生物学评估，并在其他经历粘膜炎的人群中进行额外的研究。

DESCRIPTION (provided by applicant): The broad goal of our research is development of an effective Complementary and Alternative Medicine (CAM) approach to prevent mucositis or lessen its severity and complications. Oral mucositis (OM) is a clinically challenging and debilitating side effect of conventional radiotherapy (RT), affecting almost all patients undergoing RT for head and neck cancer. OM includes inflammation of the oral mucosa with or without opportunistic microbial infection. It ranges from mild erythema to severe ulceration accompanied by persistent pain leading to inability to tolerate or swallow food and fluids. OM frequently causes unwanted cancer treatment dose reductions or breaks in therapy. Despite use of pain medications, severe OM is associated with substantially increased use of costly health care resources. Presently, there are no effective treatments for OM. The primary aim of the current proposal is to determine whether or not a mouthrinse containing an herbal extract with known anti-inflammatory and anti-microbial medicinal properties, will reduce the severity of oral mucositis in cancer patients undergoing conventional radiotherapy to the head and neck. Because of the prominent inflammatory and microbial aspects of OM we anticipate that the herbal mouthrinse will reduce the severity of the pain and secondary infections associated with OM, and will improve the quality of life in head and neck cancer patients undergoing RT. Therefore, the specific aims of our Phase II double- blind, randomized, controlled trial are 1) to determine if the severity of oral mucositis is reduced in RT patients receiving the herbal mouthrinse compared to patients receiving the comparison mouthrinse and 2) to determine the effects of the herbal mouthrinse on the microbial environment of the oral cavity and on quality of life. Findings from this study will provide evidence to support more in-depth biological assessment of the anti-inflammatory and anti-microbial mechanisms by which the herbal extract reduces oral mucositis, and additional study in other populations experiencing mucositis.