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

描述（由申请人提供）：我们研究的主要目标是开发一种有效的补充和替代医学（CAM）方法来预防粘膜炎或减轻其严重程度和并发症。口腔黏膜炎（OM）是常规放疗（RT）的临床挑战和衰弱的副作用，影响几乎所有接受RT治疗的头颈癌患者。口腔黏膜炎包括伴有或不伴有机会性微生物感染的口腔黏膜炎症。它的范围从轻微的红斑到严重的溃疡，并伴有持续的疼痛，导致无法忍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。尽管使用止痛药，严重OM与大量增加使用昂贵的卫生保健资源有关。目前，对骨髓瘤没有有效的治疗方法。当前提案的主要目的是确定含有已知抗炎和抗微生物药用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黏膜炎的严重程度。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轻OM相关的疼痛和继发感染的严重程度，并将改善接受rt治疗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)确定接受中药漱口水的RT患者与接受对照漱口水的患者相比，口腔黏膜炎的严重程度是否减轻；2)确定中药漱口水对口腔微生物环境和生活质量的影响。本研究的发现将为草药提取物减少口腔黏膜炎的抗炎和抗微生物机制提供更深入的生物学评估证据，并为其他患有黏膜炎的人群提供进一步的研究。

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.