盆腔物理治疗预防放疗后阴道狭窄 (PPPVSSR)
2017年8月21日 更新者：Fabrício Edler Macagnan、Federal University of Health Science of Porto Alegre
盆腔物理治疗预防妇科癌症放疗后阴道狭窄的随机对照试验
阴道狭窄是盆腔放疗最普遍的副作用之一，影响了大约三分之一的女性。
在这项随机对照试验中，盆腔物理治疗方案对接受妇科近距离放射治疗的妇科癌症女性阴道狭窄发生率的影响。
此外，研究人员将探索骨盆底肌肉的生活质量、性和收缩功能的改善。
研究概览
详细说明
如果妇科癌症患者接受放射治疗服务，该研究将在参考医院进行肿瘤治疗。
这项工作的目的是评估盆腔物理疗法 (PP) 对继发于近距离放射治疗的更普遍的狭窄病理学（阴道狭窄）的影响。
PP 将在放疗开始后三个月进行，阴道狭窄的发生率将在休整期的六个月内与对照组进行比较。
研究类型
介入性
注册 (预期的)
160
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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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、巴西
- 招聘中
- Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
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接触：
- Elizte Keitel, Dr
- 电话号码：+55 (51) 3214.8571
- 邮箱：cep@santacasa.tche.br
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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
有资格学习的性别
女性
描述
纳入标准：
- 18岁以上的女性；
- 初次评估无阴道狭窄；
- 以前没有接受过腔内辐射的女性；
- 在研究期间在阿雷格里港 Santa Casa de Misericórdia 的 Santa Rita 医院接受近距离放射治疗的被诊断患有妇科癌症的女性；
- 通过知情同意书 (TCLE) 同意参与研究的女性。
排除标准：
- 未签署 ICF 的女性；
- 未接受妇科癌症治疗的妇女；
- 有 30% 的女性缺乏物理治疗（4 次）；
- 存在妨碍完成盆腔物理治疗方案或未完成所有近距离放射治疗的并发症的女性。
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：骨盆物理治疗 (PP)
骨盆物理治疗包括每日盆底肌肉训练 (PFMT)。
PFMT 从近距离放射治疗的第一次疗程开始，并将在十二周的治疗期间进行。
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1）每日盆底肌训练（PFMT）。
其他名称：
1) 每日阴道扩张器治疗（10 至 15 分钟）和 2) 常规护理管理。
其他名称：
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有源比较器：斯坦德护理 (SC)
标准治疗 (SC) 包括接受放疗/近距离放射治疗的妇科癌症患者的指南： 1) 每日阴道扩张器治疗（10 至 15 分钟）； 2) 日常护理管理。
该 SC 从近距离放射治疗的第一次疗程开始，并将在十二周的治疗期间进行。
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1) 每日阴道扩张器治疗（10 至 15 分钟）和 2) 常规护理管理。
其他名称：
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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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阴道狭窄
大体时间：随着研究的完成，预测研究开始后 15 个月。
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阴道狭窄将在第一次近距离放射治疗之前和之后的 12 个月进行评估。
根据 Kirchheiner 等人（2016 年）的研究考虑，该研究使用了不良事件通用术语标准 (CTCAE v3.0)。
阴道狭窄也被认为是阴道管变窄，无法通过阴道口引入 1 号丙烯酸妇科窥器。
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随着研究的完成，预测研究开始后 15 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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生活质量
大体时间：随着研究的完成，预测研究开始后 15 个月。
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生活质量将在第一次近距离放射治疗之前和十二个月后通过应用欧洲癌症研究和治疗组织 - EORTC QLQ-C30 生活质量问卷进行评估。
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随着研究的完成，预测研究开始后 15 个月。
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性欲
大体时间：随着研究的完成，预测研究开始后 15 个月。
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将在第一次近距离放射治疗前和十二个月后通过应用女性性功能指数 (FSFI) 问卷评估性征。
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随着研究的完成，预测研究开始后 15 个月。
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盆底肌肉活动和收缩功能
大体时间：随着研究的完成，预测研究开始后 15 个月。
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骨盆底活动的测量将在第一次近距离放射治疗前和十二个月后通过表面肌电图 (EMG) 进行评估，EMG 能够通过 Miotec 的肌电生物反馈 Miotool 400 记录肌肉纤维产生的细胞外生物电活动。
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随着研究的完成，预测研究开始后 15 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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阴道区
大体时间：随着研究的完成，预测研究开始后 15 个月。
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阴道区域将在第一次近距离放射治疗前和十二个月后通过八种不同尺寸（以平方厘米为单位）的 A-SÒS 标记的阴道扩张器进行评估，阴道长度将用宫腔计测量，引入阴道管直至到达子宫颈（从腹环到后穹窿），测量单位为厘米。
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随着研究的完成，预测研究开始后 15 个月。
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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
- 学习椅：Taís M Cerentini, Bela.、Federal University of Health Science of Porto Alegre
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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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 (预期的)
2017年8月21日
初级完成 (预期的)
2018年5月31日
研究完成 (预期的)
2018年7月31日
研究注册日期
首次提交
2017年1月12日
首先提交符合 QC 标准的
2017年3月20日
首次发布 (实际的)
2017年3月24日
研究记录更新
最后更新发布 (实际的)
2017年8月22日
上次提交的符合 QC 标准的更新
2017年8月21日
最后验证
2017年8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.