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

草药漱口水治疗癌症患者放疗引起的粘膜炎的随机对照试验

• 批准号: 8443649
• 负责人: SUSAN Gayle REED
• 金额: $ 19.25万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-01 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8443649
• 关键词: Address; Adverse effects; Affect; Analgesics; Anti-Inflammatory Agents; Anti-inflammatory; Applications Grants; Ayurvedic Medicine; Azadirachta indica; Biological; Cancer Patient; Candida; Collaborations; Complementary and alternative medicine; Deglutition; Dental; Development; Dose; Double-Blind Method; Enrollment; Environment; Erythema; Feasibility Studies; Food; Foundations; Goals; Head and Neck Cancer; Head and neck structure; Health Resources; Healthcare; Human; India; Infection; Inflammation; Inflammatory; Intervention; Liquid substance; Medical; Mucositis; Oral; Oral cavity; Oral health; Oral mucous membrane structure; Pain; Participant; Patients; Persistent pain; Pharmacopoeias; Pharyngeal structure; Phase; Plant Leaves; Population; Procedures; Property; Protocols documentation; Public Health; Quality of life; Questionnaires; Radiation therapy; Randomized Controlled Trials; Research; Resources; Saliva; Science; Severities; Solid; Southeastern Asia; Streptococcus mutans; System; Testing; Traditional Medicine; Trees; Ulcer; Visit; antimicrobial; antimicrobial drug; cancer care; cancer therapy; cancer type; cost; design; economic impact; effective intervention; effective therapy; efficacy testing; experience; head and neck cancer patient; improved; microbial; novel; novel therapeutics; oral mucositis; phase 3 study; prevent; public health relevance; response; secondary infection

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.

描述（由申请人提供）：我们研究的总体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。口腔粘膜炎 (OM) 是传统放疗 (RT) 的一种具有临床挑战性和令人衰弱的副作用，几乎影响所有接受头颈癌放疗的患者。 OM 包括伴有或不伴有机会性微生物感染的口腔粘膜炎症。其范围从轻度红斑到严重溃疡，并伴有持续疼痛，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。尽管使用止痛药物，严重的 OM 仍与昂贵的医疗资源的使用大幅增加有关。目前，OM 尚无有效治疗方法。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减轻接受常规头部和颈部放射治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轻与 OM 相关的疼痛和继发感染的严重程度，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、对照试验的具体目的是 1) 确定接受草药漱口水的 RT 患者与接受对照漱口水的患者相比，口腔粘膜炎的严重程度是否有所减轻；2) 确定草药漱口水对口腔微生物环境和生活质量的影响。这项研究的结果将为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提供证据，并支持对其他患有粘膜炎的人群进行进一步的研究。