ARMOR Trial

装甲试炼

• 批准号: 10228583
• 负责人: Patricia M Corby
• 金额: $ 66.1万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10228583
• 关键词: Adverse effects; Affect; Analgesics; Antibiotics; Applications Grants; Award; Bacteria; Biochemical; Biological Markers; Cancer Patient; Clinical; Clinical Trials; Control Groups; Dehydration; Dental Calculus; Dental Hygiene; Dental Plaque; Development; Discipline; Environment; Etiology; Event; Excision; Exposure to; Future; Gastrostomy; Head and Neck Cancer; Head and neck structure; Inflammation; Inflammatory; Intake; Intervention; Intervention Studies; Intervention Trial; Intravenous; Lead; Length of Stay; Malignant Neoplasms; Malnutrition; Measures; Mechanics; Microbiology; Minor; Modeling; Molecular; Monitor; Morbidity - disease rate; Mucositis; Mucous Membrane; Nutritional; Oral; Oral cavity; Oral health; Oral mucous membrane structure; Pain; Pathway interactions; Patients; Pharmaceutical Preparations; Pharyngeal structure; Population; Preventive treatment; Protocols documentation; Quality of life; Radiation therapy; Randomized; Randomized Controlled Clinical Trials; Regimen; Research; Risk; Salivary; Severities; Testing; Therapeutic Intervention; Time; Tissues; Toxic effect; Tube; Ulcer; Virulence Factors; Virus; Xerostomia; anti-cancer; anticancer treatment; antimicrobial drug; bacteriome; base; cancer therapy; care costs; chemoradiation; clinical practice; clinically significant; cytokine; cytotoxic; design; dosage; effective therapy; evidence base; fungus; head and neck cancer patient; healing; host-microbe interactions; improved; infection rate; infection risk; irritation; microbial; microbiome; microorganism; mycobiome; novel; oral care; oral commensal; oral microbial community; oral microbiome; oral mucositis; oral tissue; pain relief; prevent; radiation effect; response; standard of care; targeted agent; targeted treatment; yeast infection

Project Summary/Abstract Oral mucositis is among the most common, painful, and debilitating toxicities of cancer treatment. OM presents as large, irregular, deep ulcers of the movable mucosa, often covered by a pseudomembrane. Among patients receiving aggressive anti-cancer regimes a dramatic change in the oral environment occurs causing an imbalance of the bacteria, fungi, and viruses of the oral cavity. Currently, there are no effective therapies or preventive treatments for OM. Most suggested treatments or therapies provide minor improvements in infection rates, inflammation, irritation, or pain relief. OM occurs in 80% of patients receiving radiation therapy (RT) or chemoradiation therapy (chemoRT) for head and neck malignancies; severe mucositis affects more than two- thirds of this population. Pain, malnutrition, dehydration, and risk of infection all contribute to the morbidity of OM. In patients with severe OM, nutritional intake is drastically reduced, and the cost of care is increased due to the necessity of percutaneous endoscopic gastrostomy tube insertion, administration of systemic analgesics and intravenous antibiotics, and prolonged hospital stay. Clinically significant OM could lead clinicians to reduce the chemotherapeutic dosage, or delay or discontinue cancer therapy, which impacts definitive treatment of the cancer. Novel discoveries in OM have focused on understanding the host-microbial interactions, as current pathways have shown that major virulence factors from microorganisms have the potential to contribute to the development of OM and may even prolong the existence of already established ulcerations. Thus, intervention studies based on this pathobiological model are urgently needed for the development of better oral care treatments and/or antimicrobial agents targeted at the treatment of OM. Our proposed study will investigate in a randomized controlled clinical trial the effects of a novel oral care protocol on the severity of OM in patients undergoing RT and chemoRT for head and neck cancer. Additionally, it will evaluate the effect of RT/chemoRT on the oral microbiome and its impact on OM severity and local inflammation. The central hypothesis is that a weekly regimen of targeted professional oral care during cancer treatment prevents harmful ecological shifts in the oral cavity and consequently reduces the duration and severity of OM, reduces OM local inflammation, and improves oral health, thereby improving overall quality of life during cancer treatment. The rationale is that the cleansing of dead, damaged, or infected oral mucosal tissues in combination with the mechanical removal of dental plaque and calculus in the oral cavity improves the healing potential of the oral tissues and suppresses OM severity. Hence, findings from our study may identify important biochemical and microbiological alterations that can be targeted in the future as well as inspire further etiological studies of the OM microbiome, which may lead to better-targeted oral health preventive treatments, interventions and therapies aimed at improving quality of life during cancer treatment.

项目摘要/摘要 口腔粘膜炎是癌症治疗的最常见，痛苦和衰弱的毒性。 OM礼物 与可移动的粘膜的不规则，不规则，深层溃疡，通常被假膜覆盖。在患者中 接受积极的反癌政权，口腔环境发生了巨大变化，导致 细菌，真菌和口腔病毒的不平衡。目前，没有有效的疗法或 OM的预防治疗。大多数建议的治疗方法或疗法对感染提供了较小的改善 发生率，炎症，刺激或缓解疼痛。 OM发生在80％接受放射治疗（RT）或 用于头颈恶性肿瘤的化学加载疗法（化学）；严重的粘膜炎会影响超过两个 该人群的三分之一。疼痛，营养不良，脱水和感染风险都有助于 om。在严重OM的患者中，营养摄入量大大降低，护理成本应得 对于经皮内窥镜胃造口管插入的必要性，全身镇痛药给药 和静脉注射抗生素，并长期住院。临床意义的OM可能会导致临床医生到 减少化学治疗剂量，或延迟或停止癌症治疗，这会影响确定性 治疗癌症。 OM中的新发现专注于理解宿主微生物 相互作用，因为目前的途径表明，微生物的主要毒力因子具有 有可能为OM的发展做出贡献，甚至可能延长已经建立的 溃疡。因此，迫切需要基于此病理生物学模型的干预研究 开发针对OM治疗的更好的口腔护理治疗和/或抗菌剂。 我们提出的研究将在一项随机对照临床试验中调查新口服的影响 对正在接受RT的患者和头颈癌化学的患者OM严重程度的护理方案。 此外，它将评估RT/Chemort对口腔微生物组的影响及其对OM严重性的影响 和局部炎症。中心假设是针对性专业口腔护理的每周一次 在癌症治疗期间，可以防止口腔中有害生态转移，因此减少了 OM的持续时间和严重性，减少OM局部炎症并改善口腔健康，从而改善 癌症治疗期间的整体生活质量。理由是清洁死亡，受损或感染 口服粘膜组织与口腔中的牙菌斑和微积分的机械去除 空腔改善口腔组织的愈合潜力并抑制OM的严重程度。 因此，我们研究的发现可能确定重要的生化和微生物变化， 可以将来针对的目标，并激发对OM微生物组的进一步病因研究，这可能 导致靶向更好的口腔健康预防疗法，旨在改善的疗法 癌症治疗期间的生活质量。