Oral mucositis risk & multicycle chemotherapy: Do multiple cycles multiply risk?

口腔粘膜炎风险

• 批准号: 7990840
• 负责人: LINDA S ELTING
• 金额: $ 16.48万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7990840
• 关键词: Accident and Emergency department; Activities of Daily Living; Address; Adverse effects; Affect; Analgesics; Bacteremia; Body Weight decreased; Breast; Chemotherapy-Oncologic Procedure; Clinic Visits; Clinical; Clinical Trials; Clinical Trials Design; Colorectal; Colorectal Cancer; Data; Data Set; Databases; Dose; Event; Fatigue; Fever; Frequencies; Funding; Future; Goals; Grant; Healthcare; Hospitalization; Industry; Injury; Knowledge; Lead; Left; Life; Longitudinal Studies; Malignant Neoplasms; Measurement; Medical Records; Methods; Modeling; Monitor; Neutropenia; Non-Hodgkin' s Lymphoma; Office Visits; Opioid; Oral cavity; Outcome; Outpatients; Pain; Patient Outcomes Assessments; Patients; Pattern; Pharyngeal structure; Predictive Value; Prevalence; Prevention; Preventive; Protocols documentation; Quality of life; Radiation; Radiation therapy; Recruitment Activity; Reporting; Resources; Risk; Risk Estimate; Severities; Site; Solid Neoplasm; Techniques; Tissues; Treatment Protocols; Variant; Visit; base; burden of illness; cancer therapy; chemotherapy; clinical decision-making; clinically significant; cohort; cost; design; experience; follow-up; functional status; head and neck cancer patient; health care service utilization; impression; malignant breast neoplasm; novel therapeutics; oral mucositis; patient population; predictive modeling; prospective; public health relevance; secondary outcome; standard of care; tool

DESCRIPTION (provided by applicant): Oral mucositis (OM) is a painful and debilitating consequence of cancer therapy, but its risk and outcomes during standard dose, multi-cycle chemotherapy are poorly described. The lack of such information compromises clinical decision making and design of clinical trials addressing prevention of OM. The objectives of this study are to 1) characterize the relationship between clinically significant OM during chemotherapy and its risk during subsequent chemotherapy cycles, 2) develop a predictive model of subsequent cycle risk and to assess the model's predictive value, and 3) to describe associations between OM and clinical and patient-reported outcomes. OM risk and outcomes will be studied in 177 patients with colorectal or breast cancers or non-Hodgkins lymphoma during 1121 cycles of chemotherapy. The chemotherapy regimens reflect the current standard of care for these cancers, worldwide (FolFOX, FolFIri, TAC, AC+T, and CHOP). Data will be obtained from an existing database of OM risk and outcomes created during a multi-center, prospective, longitudinal study of cancer treatment-induced OM. These objectives were not posed during the original study. However, the data are ideally suited to answering this question because patient reported OM and outcomes were collected daily during multiple cycles of chemotherapy using previously validated tools. Risk of clinically significant OM (percentage of patients or cycles affected) will be estimated, per cycle, then modeled using multivariate techniques. Subsequent cycle risk will be estimated, conditioned on previous cycle risk and severity, and modeled in similar fashion. Patterns of outcomes and resource utilization will be examined over multiple chemotherapy cycles. The clinical outcomes are weight loss, requirement for opioids, delays in planned therapy, dose reductions, and episodes of febrile neutropenia or bacteremia. The patient- reported outcomes are interference with activities of daily living, pain medication usage, and fatigue and quality of life scores. The healthcare resources are unplanned outpatient office visits, emergency room visits, and hospitalizations. Information resulting from this study will be instrumental in identifying solid tumor patients at risk of clinically significant OM or its serious outcomes for participation in clinical trials of new preventive agents. PUBLIC HEALTH RELEVANCE: The goal of this study is to determine whether the risk or severity of chemotherapy-induced injury to the mouth and throat tissues is higher among patients who have experienced this injury during a previous cycle of chemotherapy. This information is critical to clinical decisions about use of high cost preventive agents and frequency of clinic visits for side effect monitoring; it is also critical to design of clinical trials of new therapeutics.

描述（由申请人提供）：口腔粘膜炎（OM）是癌症治疗的一种痛苦且令人衰弱的后果，但其在标准剂量、多周期化疗过程中的风险和结果却很少被描述。缺乏此类信息会影响预防 OM 的临床决策和临床试验设计。 本研究的目的是 1) 表征化疗期间临床显着的 OM 与其后续化疗周期风险之间的关系，2) 开发后续周期风险的预测模型并评估该模型的预测价值，3) 描述相关性OM 与临床和患者报告的结果之间的关系。 将在 177 名结直肠癌、乳腺癌或非霍奇金淋巴瘤患者的 1121 个化疗周期中研究 OM 风险和结果。化疗方案反映了全球这些癌症的当前护理标准（FolFOX、FolFIri、TAC、AC+T 和 CHOP）。数据将从癌症治疗引起的 OM 的多中心、前瞻性、纵向研究期间创建的 OM 风险和结果的现有数据库中获取。这些目标并未在最初的研究中提出。然而，这些数据非常适合回答这个问题，因为患者报告的 OM 和结果是使用先前验证的工具在多个化疗周期期间每天收集的。 每个周期都会估计有临床意义的 OM（受影响的患者或周期的百分比）的风险，然后使用多变量技术进行建模。将根据先前周期的风险和严重程度来估计后续周期风险，并以类似的方式建模。将在多个化疗周期中检查结果和资源利用的模式。临床结果是体重减轻、需要阿片类药物、计划治疗延迟、剂量减少以及发热性中性粒细胞减少症或菌血症发作。患者报告的结果是对日常生活活动的干扰、止痛药物的使用以及疲劳和生活质量评分。医疗保健资源包括计划外的门诊就诊、急诊室就诊和住院治疗。 这项研究产生的信息将有助于识别有临床意义的 OM 风险或其严重后果的实体瘤患者，以参与新预防药物的临床试验。 公共卫生相关性：本研究的目的是确定在上一个化疗周期中经历过​​这种损伤的患者中，化疗引起的口腔和咽喉组织损伤的风险或严重程度是否较高。这些信息对于有关使用高成本预防药物的临床决策以及副作用监测的就诊频率至关重要；新疗法的临床试验设计也至关重要。