CLINICAL TRIAL: DEXAMETHASONE-SPARING STUDY COMPARING (HERF) TO PLACEBO

临床试验：地塞米松节约研究 (HERF) 与安慰剂的比较

• 批准号: 7717882
• 负责人: Lawrence D Recht
• 金额: $ 0.06万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717882
• 关键词: Adverse effects; Blinded; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Daily; Data Element; Deterioration; Dexamethasone; Dose; Double-Blind Method; Drops; End Point; Failure; Funding; Grant; Institution; Karnofsky Performance Status; Label; Measures; Medical; Monitor; Myopathy; Neoplasm Metastasis; Nervous System Physiology; Neurologic Examination; Patients; Performance; Pharmaceutical Preparations; Placebo Control; Placebos; Quality of life; Randomized; Relative (related person); Research; Research Personnel; Resources; Safety; Score; Signal Transduction; Source; Steroids; Symptoms; Time; United States National Institutes of Health; Visit; Week; day; follow-up

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Two hundred patients, randomized to one of two treatment groups, will participate in this double blind, placebo-controlled, 12-week study. Patient randomization will be stratified by (1) primary or metastatic tumor, (2) open-label dexamethasone dose at Baseline (4-<8 mg/day, 8-16 mg/day or 17-24 mg/day) and (3) Karnofsky Performance Scale (50-70 or 80-100). Attempts will be made to reduce daily dexamethasone dose by 50% during the first two weeks of the 12-week study. The 50% reduction is to be maintained until Week 5, after which further reductions may be attempted at the discretion of the Investigator. The primary endpoint is the proportion of patients in each treatment group who are Responders at Week 2 and who continue to be Responders at Week 5. Responders are defined as study patients who demonstrate the following: (a) 50% or greater reduction in dexamethasone dose relative to Baseline; (b) overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline (c) Karnofsky Performance Score unchanged or increased compared to Baseline. All patients not fulfilling the definition of Responder for any reason, including missing data elements, patient drop out, or failure to achieve a 50% reduction in dexamethasone without deterioration in neurological function as measured by the 10- Item Neurological Examination Score and the Karnofsky Performance Score will be scored as non-responders. Further dexamethasone reductions after Week 5, overall safety and steroid associated side effects will be evaluated over the course of the trial. Secondary efficacy endpoints include the following: percent of patients in each treatment group achieving 50% reduction in dexamethasone usage relative to Baseline by Week 2 without deterioration in neurological function; the proportion of patients in each treatment group who are Responders at Week 2 and who continue to be Responders at Weeks 5 and 8. In addition, change from Baseline will be examined for the signal symptom, FACT-Br quality of life module results; myopathy assessment results. From Baseline through Week 5 of study treatment, it is mandatory that the Neurological Examinations be conducted by the same examiner. All efforts will be made to assure that the same investigator perform the Neurological Examinations after Week 5. A Follow-up visit will occur at Week 16. For patients who do not reach a 50% dexamethasone dose reduction by Week 2, continued tapering attempts must be discussed with the Medical Monitor. Patients who discontinue blinded study drug early will be seen for an Early Study Drug Discontinuation visit at time of discontinuation. All patients will have a final Follow-up visit at Week 16. For patients who discontinue study drug prior to Week 10, an additional Unscheduled Follow-up will occur 4 weeks after early study drug discontinuation.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 200名患者随机分为两个治疗组，将参加这项为期12周的双盲、安慰剂对照研究。患者的随机分组将根据(1)原发或转移肿瘤，(2)基线水平的开放标记地塞米松剂量(4-8毫克/天、8-16毫克/天或17-24毫克/天)和(3)卡诺夫斯基表现评分(50-70或80-100)来分层。 在这项为期12周的研究的头两周，将尝试将地塞米松的日剂量减少50%。50%的减幅将维持到第5周，在此之后，调查员可酌情尝试进一步减量。主要终点是每个治疗组中在第2周成为应答者和在第5周继续成为应答者的患者的比例。应答者被定义为研究患者，他们表现出以下情况：(A)地塞米松剂量与基线相比减少了50%或更多；(B)与基线相比，10项神经检查的总分数保持不变或更低；(C)Karnofsky表现评分与基线相比保持不变或增加。所有因任何原因不符合应答者定义的患者，包括数据元素缺失、患者退出或未能在不恶化神经功能的情况下将地塞米松减少50%(以10项神经检查评分和Karnofsky绩效评分衡量)，将被评为无应答者。5周后进一步减少地塞米松，总体安全性和与类固醇相关的副作用将在试验过程中进行评估。次要疗效终点包括：在没有神经功能恶化的情况下，每个治疗组在第2周达到地塞米松使用量较基线减少50%的患者的百分比；在第2周成为应答者，以及在第5周和第8周继续成为应答者的患者的比例。此外，将检查与基线的变化，以确定信号症状、FACT-BR生活质量模块结果、肌病评估结果。 从基线到研究治疗的第5周，神经学检查必须由同一检查员进行。将尽一切努力确保在第5周后由同一名调查员进行神经学检查。第16周将进行后续访问。 对于到第二周仍未达到50%地塞米松剂量减少量的患者，必须与医学监测人员讨论继续减少剂量的尝试。早期停止盲目研究药物的患者将在停止时被视为早期研究药物停止访问。所有患者将在第16周进行最后一次随访。对于在第10周之前停止研究药物的患者，在早期研究药物停止后4周将进行额外的计划外随访。