氯沙坦减少乳腺癌患者辐射引起的纤维化
2023年10月13日 更新者：Patricia Hardenbergh、Shaw Cancer Center
氯沙坦减少乳腺癌患者辐射诱导纤维化的初步研究
一项随机、双盲、安慰剂对照试验，评估氯沙坦在减少乳腺癌患者术后接受标准护理放射治疗的辐射诱导纤维化方面的作用。
研究概览
详细说明
这项单点研究将在科罗拉多州爱德华兹的邵氏癌症中心进行，以检验氯沙坦将减少乳腺癌患者辐射诱导的纤维化发展的假设。 将使用块、双盲、安慰剂对照、随机的 II 期试验来检验这一假设。
研究参与者将被手术干预（保乳手术与乳房切除术）阻断，然后以 1:1 的比例随机分配到治疗组和对照组，总共有四个研究组。 研究团队和研究参与者将对研究组不知情，并且将使用安慰剂来减少结果报告中的检测偏差。 选择偏差将通过研究组的随机化最小化。
研究参与者将服用 12.5 毫克的安慰剂胶囊或研究药物氯沙坦，每天口服两次。 治疗开始日期将是受试者开始放射治疗的那一天。 放射治疗将继续按照当地诊所程序进行。 放射治疗完成后，研究干预治疗将持续一年。 在完成放射治疗后的两年内，将评估所有参与者的纤维化、美容结果和再次手术的发生率。
研究类型
介入性
注册 (估计的)
40
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Katie Hess, Bachelors
- 电话号码：7874 (970) 485-7874
- 邮箱：katherine.hess@vailhealth.org
研究联系人备份
- 姓名：Paige Bordelon, MPH
- 电话号码：(970) 569-7806
- 邮箱：paige.bordelon@vailhealth.org
学习地点
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Colorado
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Edwards、Colorado、美国、81632
- 招聘中
- Vail Health Shaw Cancer Center
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接触：
- Katie Hess, Bachelors
- 电话号码：970-485-7874
- 邮箱：katherine.hess@vailhealth.org
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接触：
- Paige Bordelon, MPH
- 电话号码：(970) 569-7608
- 邮箱：paige.bordelon@vailhealth.org
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 诊断为临床或病理 0-IV 期浸润性乳腺癌，包括导管原位癌 (Tis)、原发肿瘤无法评估 (TX) 和所有其他原发肿瘤分期类别 (T1-T4)
- 接受过保乳手术或乳房切除重建术
- 是根据美国国家综合癌症网络 (NCCN) 指南进行单侧术后放射治疗的候选者
- 年龄 ≥ 18
- 女性
纳入妇女和少数民族：任何种族和民族的妇女都有资格参加本试验。 怀孕或哺乳的妇女被排除在该试验之外。
排除标准：
- 复发性乳腺癌或既往乳房放射治疗史
- 需要双侧乳房/胸壁放射治疗的乳腺癌
- 放疗前对侧乳房缩小的保乳手术患者
- 术后感染史
- 正在进行同步化疗
- 有记录的跌倒风险
- 活动性已知或疑似全身性自身免疫性疾病（除了白癜风、仅需要激素替代治疗的残留自身免疫性甲状腺功能减退症、两年内不需要全身治疗的银屑病、在没有外部触发因素的情况下预计不会复发的病症）或任何全身性病史炎症性关节炎，如银屑病、类风湿、系统性狼疮、强直性脊柱炎或反应性关节炎
不受控制的并发疾病，包括但不限于：
- 高钾血症
- 肾功能受损
- 症状性充血性心力衰竭
- 不稳定型心绞痛
- 肾脏疾病
- 不受控制的糖尿病
- 囊性纤维化
- 基于美国风湿病学会标准的纤维肌痛
同时使用：
- 其他肾素-血管紧张素系统 (RAS) 药物
- 增加血清钾的药物
- 锂
- 阿利吉仑治疗糖尿病
- 已知对氯沙坦中的任何活性或非活性成分过敏
- 无法耐受口服药物
- 辐射后一年内怀孕或哺乳或计划怀孕
已知拥有 DNA 修复基因的个体包括：
- 共济失调-毛细血管扩张症突变 (ATM)
- 双链断裂修复蛋白 rad21 同系物 (RAD21)
- 转化生长因子 β-1 基因中的 C-to-T 单核苷酸多态性 (C-509T)
- 患有任何疾病的患者，包括实验室或病史或基线评估中的发现，（根据主要临床研究者或其指定人员的意见），构成参与研究的风险或禁忌症或可能干扰与研究进行、终点评估或阻止受试者完全参与研究的所有方面
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：氯沙坦保乳手术
接受保乳手术的参与者将从放射治疗的第一天开始每天服用一次 25 毫克口服胶囊氯沙坦，直到放射治疗完成后一年。
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氯沙坦 25 毫克口服胶囊
其他名称：
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安慰剂比较：安慰剂保乳手术
接受保乳手术的参与者将从放射治疗的第一天开始每天服用一次 25 毫克口服胶囊安慰剂，直到放射治疗完成后一年。
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安慰剂 25 毫克口服胶囊
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实验性的：氯沙坦乳房切除术
接受乳房切除术的参与者将从放射治疗的第一天开始每天服用一次 25 毫克口服胶囊氯沙坦，直到放射治疗完成后一年。
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氯沙坦 25 毫克口服胶囊
其他名称：
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安慰剂比较：乳房切除术与安慰剂
接受乳房切除术的参与者将从放射治疗的第一天开始每天服用一次 25 毫克口服胶囊安慰剂，直到放射治疗完成后一年。
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安慰剂 25 毫克口服胶囊
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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受辐射乳腺癌患者的乳房或重建乳房纤维化
大体时间：基线、3、6、12 和 18 个月随访
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纤维化将由放射肿瘤学提供者使用晚期效应正常组织工作组 (LENT) - 主观、客观、管理、分析 (SOMA) (LENT-SOMA) 量表进行评估。
0=不存在纤维化，无法检测到。
1=纤维化几乎无法触及； 2=确定增加的密度； 3=非常显着的密度、回缩性、坚固性和固定性
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基线、3、6、12 和 18 个月随访
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乳腺癌患者放射野放射学肺纤维化
大体时间：基线、3 个月和 12 个月随访
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放射学肺纤维化将通过胸部高分辨率 CT 扫描进行评估。
胸部 CT 扫描将与放射计划 CT 扫描融合，以确认纤维化与放射野的重叠。
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基线、3 个月和 12 个月随访
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细胞衰老、转化生长因子 β-1 (TGF-β1) 和衰老相关分泌表型 (SASP) 血清生物标志物的平均水平
大体时间：基线、最后一次放射治疗分数的日期、3 个月和 12 个月的随访
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将在治疗组和对照组中对细胞衰老和衰老相关分泌表型（SASP）（包括 TGF-β 和炎症）进行量化。
将利用一种新颖且专业的方法来测量血清中的衰老细胞。
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基线、最后一次放射治疗分数的日期、3 个月和 12 个月的随访
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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乳房体积的变化
大体时间：基线、6、12 和 18 个月随访
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将按常规随访间隔计算双侧乳房 X 线摄影测定的乳房体积。
将通过监测受治疗乳房的乳房体积从基线到放射治疗完成后 18 个月的变化来评估与放射诱导纤维化相关的乳房萎缩。
测量两个乳房的乳房体积时，将使用从头尾投影得出的乳房高度（以厘米 (cm) (H) 为单位）、乳房宽度（以厘米 (W) 为单位）和压缩厚度（以厘米 (C) 为单位）。
体积以毫升 (mL) 为单位 = (π/4) x 高 x 宽 x C。乳房 X 光检查还将提供从乳头到胸肌的乳头线上的距离测量（以厘米为单位）以及从上胸肌到乳头肌的长度测量（以厘米为单位）。以 90° 角平分乳头后线 (PNL) 的下缘。
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基线、6、12 和 18 个月随访
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美容
大体时间：基线、3、6、12 和 18 个月随访
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美容将使用临床医生评估哈佛美容量表进行评估： 1 = 优秀（治疗后的乳房与未治疗的乳房几乎相同）； 2=良好（治疗过的乳房与未治疗过的乳房略有不同）； 3=一般（经过治疗的乳房与未经治疗的乳房明显不同，但没有扭曲）； 4=处理不良的乳房严重变形。
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基线、3、6、12 和 18 个月随访
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患者报告的结果
大体时间：基线、3、6、12 和 18 个月随访
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参与者自我报告的生活质量将通过 Breast-Q 重建模块进行评估。 Breast-Q 2.0 版工具旨在评估参与者对心理和满意度领域临床结果的看法。
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基线、3、6、12 和 18 个月随访
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再次操作符号
大体时间：放射治疗完成后的任何时间，在 6、12 和 18 个月的随访中进行评估
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将在每个时间点记录参与者在放射后对任一乳房进行矫正手术的决定。
如果在永久种植体植入后进行矫正手术，则乳房切除术后患者将被视为再次手术。
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放射治疗完成后的任何时间，在 6、12 和 18 个月的随访中进行评估
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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再手术发生率
大体时间：放射治疗完成后两年
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患者可能会选择再次手术以纠正可能与辐射诱发的纤维化相关的不良结果。
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放射治疗完成后两年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Patricia H Hardenbergh, MD、Medical Director
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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- Centers for Disease Control and Prevention (CDC). United States Cancer Statistics: Data Visualizations. (2020)
- Medicine, N. N. L. o. Breast Cancer (2022)
- FDA. HIGHLIGHTS OF PRESCRIBING INFORMATION (2022)
- Institute, N. N. C. Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) (2021)
研究记录日期
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研究主要日期
学习开始 (实际的)
2023年8月17日
初级完成 (估计的)
2027年8月17日
研究完成 (估计的)
2027年8月17日
研究注册日期
首次提交
2022年11月10日
首先提交符合 QC 标准的
2022年11月23日
首次发布 (实际的)
2022年12月5日
研究记录更新
最后更新发布 (实际的)
2023年10月16日
上次提交的符合 QC 标准的更新
2023年10月13日
最后验证
2023年10月1日
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其他研究编号
- 2022-155
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