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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 将200例随机分为两个治疗组之一的患者将参加这项双盲，安慰剂对照，为期12周的研究。患者随机分组将通过（1）原发性或转移性肿瘤，（2）基线时（4- <8 mg/day，8-16 mg/day或17-24 mg/day）和（3）Karnofsky绩效量表（50-70或80-100）时（4- <8 mg/day，8-16 mg/day或17-24 mg/day）。 在这项为期12周的研究的前两周中，将尝试将每日地塞米松剂量减少50％。将维持50％的减少到第5周，然后可以酌情决定进一步减少。主要终点是每个治疗组的患者比例在第2周是反应者，并且在第5周继续成为响应者。响应者被定义为研究患者，这些患者证明了以下内容：（a）地塞米松剂量相对于基线的50％或更高的降低； （b）与基线相比，与基线相比，与基线相比，与基线相比，总体10个项目神经检查评分不变或较低。由于任何原因，所有患者均未履行响应者的定义，包括缺少数据元素，患者辍学或未能使地塞米松降低50％，而不会通过10项神经系统检查评分和Karnofsky表现评分来衡量神经功能的恶化功能，将被评分为非响应者。第5周后，进一步的地塞米松减少，在试验过程中将评估总体安全性和类固醇相关的副作用。次级功效终点包括以下内容：每个治疗组中的患者百分比相对于基线，而在第2周之前，地塞米松的使用率降低了50％，而神经系统功能的降低而没有恶化；每个治疗组的患者比例在第2周为反应者，并在第5周和第8周继续成为响应者。此外，还将检查基线的变化，以应对信号症状，事实-BR的生活质量模块结果；肌病评估结果。 从研究治疗的基线到第5周，必须由同一检查员进行神经检查。将尽一切努力确保同一研究人员在第5周后进行神经检查。将在第16周进行后续访问。 对于在第2周之前未达到50％地塞米松剂量的患者，必须与医疗监测仪讨论持续的逐渐减少尝试。停止盲目研究药物的患者将在停用时进行早期研究药物停用访问。所有患者将在第16周进行最终的随访。对于第10周之前停止学习药物的患者，在早期研究药物中断后4周，将进行额外的外止随访。