稳定运动研究 (WISER) 幸存者试验中的女性 (WISER Survivor)
2022年10月6日 更新者：Milton S. Hershey Medical Center
稳定运动研究中的女性 (WISER) 幸存者试验和疾病成本以及替代管理策略的成本效益
WISER Survivor 是一项为期一年的减肥和运动研究，针对超重或肥胖并伴有乳腺癌相关淋巴水肿的久坐不动的乳腺癌幸存者。
该试验将分为四组：仅运动组、仅减肥组、运动和减肥相结合的组以及对照组。
本研究的主要目的是测试这些干预措施对临床淋巴水肿结果的影响。
次要结果包括体重减轻、乳腺癌相关生物标志物和生活质量。
在资金可用的范围内，参与者将被长期跟踪以检查对复发和死亡率的影响。
研究概览
研究类型
介入性
注册 (实际的)
450
阶段
- 不适用
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。
学习地点
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- The Penn TREC Survivorship Center
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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
不超过 80年 (成人、OLDER_ADULT、孩子)
接受健康志愿者
是的
有资格学习的性别
女性
描述
纳入标准：
- 乳腺癌幸存者
- 超重或肥胖（BMI 为 25 或更高）
- 必须患有乳腺癌相关的淋巴水肿
- 治疗后至少 6 个月（例如 手术、化学疗法或放射疗法），但诊断后的时间没有上限
- 符合条件的年龄范围将没有下限。
- 目前没有癌症
排除标准：
- 会禁止参加锻炼计划或会对我们测试主要目标的能力产生负面影响的医疗条件或药物
- 无法独立行走 6 分钟
- 极度肥胖（体重指数大于或等于 50 kg/m2）
- 额外的计划（例如 研究期间的治疗性或重建性）手术
- 过去一年内举重的自我报告
- 已经每周进行 3 次或更多次中等强度的有氧运动
- 计划明年搬离该地区
- 当前使用的减肥药（非处方药或处方药）
- 自我报告过去 12 个月内酗酒或滥用药物，包括有饮酒风险（目前每周饮用超过 14 种酒精饮料）
- 过去 3 个月体重减轻超过 10%
- 减肥手术史
- 怀孕的妇女
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：支持性护理
- 分配：随机化
- 介入模型：平行线
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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NO_INTERVENTION：仅淋巴水肿护理
所有 4 组都接受如下淋巴水肿护理：
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实验性的：仅限运动
锻炼干预将每周两次 60-90 分钟的监督举重课程与每周 180 分钟的有氧运动相结合。
女性将由经过认证的健身专家进行举重干预和安全增加有氧运动活动的培训，每周 6 次，然后通过电话联系和每月面对面的会议进行监控。
所有锻炼参与者都将获得“Power Blocks”，这是一种可调节的哑铃，他们可以用它从 1-21 磅以 1-2 磅的增量增加阻力。
除了前 6 周的训练和每月的登记训练外，所有重量训练都将在他们的家中进行。
仅运动组成员也接受了上述淋巴水肿护理干预。
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运动干预将 PAL 每周两次的举重干预与最近完成的 WISER 试验和正在进行的 WISER Sister 试验中每周 180 分钟的有氧运动相结合。
女性将由经过认证的健身专业人员进行 PAL 举重干预和安全增加有氧运动活动的培训，每周 6 次，然后通过电话联系和每月面对面的会议进行监控。
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实验性的：仅减肥
减重干预从为期 24 周的强化阶段开始，包括每周例会和提供商业制造商（NutriSystem®, Inc., Fort Washington, PA）提供的所有膳食和零食。
在最初的 24 周内，每天的热量摄入将严格控制在 1200-1500 卡路里。
将指导参与者每天保持相同数量的卡路里，直到达到目标体重，然后逐渐增加卡路里摄入量（大约 500 卡路里/天）以在整个干预的剩余时间内保持体重。
治疗组将由注册营养师领导，并将通过电话和电子邮件联系方式接受持续监督。
仅减肥组成员也接受了上述淋巴水肿护理干预。
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减重干预从为期 24 周的强化阶段开始，包括每周例会和提供商业制造商（NutriSystem, Inc., Fort Washington, PA）提供的所有膳食和零食。
在最初的 24 周内，每天的热量摄入将严格控制在 1200-1500 卡路里。
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实验性的：运动减肥相结合
该小组的参与者将接受每周两次的监督重量训练课程和减肥计划的组合。
联合小组成员还接受了上述淋巴水肿护理干预。
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运动干预将 PAL 每周两次的举重干预与最近完成的 WISER 试验和正在进行的 WISER Sister 试验中每周 180 分钟的有氧运动相结合。
女性将由经过认证的健身专业人员进行 PAL 举重干预和安全增加有氧运动活动的培训，每周 6 次，然后通过电话联系和每月面对面的会议进行监控。
减重干预从为期 24 周的强化阶段开始，包括每周例会和提供商业制造商（NutriSystem, Inc., Fort Washington, PA）提供的所有膳食和零食。
在最初的 24 周内，每天的热量摄入将严格控制在 1200-1500 卡路里。
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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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肢间差异百分比，在 12 个月内发生变化。
大体时间：基线和 12 个月
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受影响和未受影响肢体的手臂体积将通过透视测量法测量，差异百分比将在基线和 12 个月时确定。
差异的绝对百分比差异（12 个月时的肢间差异百分比减去基线时的肢间差异百分比）将是主要结果
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基线和 12 个月
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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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临床淋巴水肿事件
大体时间：在 12 个月的后续行动中收集的数据，以及按报告收集的事件
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突发和蜂窝组织感染（记录的数量和类型）
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在 12 个月的后续行动中收集的数据，以及按报告收集的事件
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淋巴水肿的临床评估评分
大体时间：基线和 12 个月
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由认证淋巴治疗师完成的标准化临床评估调查
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基线和 12 个月
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诺曼淋巴水肿调查
大体时间：基线和 12 个月
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标准化调查中记录的十三种症状（诺曼淋巴水肿调查）
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基线和 12 个月
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减肥
大体时间：基线和 12 个月
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12个月内体重下降
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基线和 12 个月
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生物标志物：雌二醇
大体时间：基线和 12 个月
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血液中的循环雌二醇水平
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基线和 12 个月
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生物标志物：睾酮
大体时间：基线和 12 个月
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血液中的循环睾酮水平
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基线和 12 个月
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生物标志物 - 性激素结合球蛋白
大体时间：基线和 12 个月
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血液中的循环性激素结合球蛋白水平
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基线和 12 个月
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炎症：白细胞介素六
大体时间：基线和 12 个月
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血液中的循环白细胞介素六级
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基线和 12 个月
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炎症：C反应蛋白
大体时间：基线和 12 个月
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血液中的循环 c 反应蛋白水平
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基线和 12 个月
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脂联素
大体时间：基线和 12 个月
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血液中的循环脂联素水平
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基线和 12 个月
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瘦素
大体时间：基线和 12 个月
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血液中的循环瘦素水平
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基线和 12 个月
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F2-异前列腺素
大体时间：基线和 12 个月
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血液中的循环 F2-异前列腺素水平
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基线和 12 个月
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胰岛素
大体时间：基线和 12 个月
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血液中的循环胰岛素水平
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基线和 12 个月
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葡萄糖
大体时间：基线和 12 个月
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血液中的循环葡萄糖水平
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基线和 12 个月
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胰岛素样生长因子一
大体时间：基线和 12 个月
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血液中胰岛素样生长因子的循环水平
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基线和 12 个月
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胰岛素样生长因子结合蛋白三
大体时间：基线和 12 个月
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血液中胰岛素样生长因子结合蛋白三的循环水平
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基线和 12 个月
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上肢淋巴水肿二十七
大体时间：基线和 12 个月
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27项淋巴水肿生活质量调查
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基线和 12 个月
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身体形象和关系调查
大体时间：基线和 12 个月
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专为乳腺癌幸存者开发的 32 项身体形象调查
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基线和 12 个月
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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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乳腺癌复发
大体时间：审判后 10 年
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将对参与者进行乳腺癌复发跟踪
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审判后 10 年
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死亡
大体时间：审判后 10 年
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将跟踪参与者的死亡率
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审判后 10 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：Kathryn H. Schmitz, MPH,PhD、Penn State University
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。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年1月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2012年1月18日
首先提交符合 QC 标准的
2012年1月18日
首次发布 (估计)
2012年1月23日
研究记录更新
最后更新发布 (实际的)
2022年10月10日
上次提交的符合 QC 标准的更新
2022年10月6日
最后验证
2022年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.