使用冷冻疗法预防乳腺癌女性紫杉醇引起的周围神经病变和指甲变化
2021年3月4日 更新者：Danielle Payne、Parkview Health
本研究将确定冷冻疗法在预防乳腺癌女性紫杉醇引起的周围神经病变和指甲变化方面的疗效。
研究概览
详细说明
接受紫杉醇治疗的乳腺癌女性将完成简要疼痛量表 (BPI)、神经性疼痛综合征量表 (NPSI)，同时研究团队的一名成员将对她们的指甲进行评估。 一旦完成，冷冻疗法将在紫杉醇输注前 15 分钟进行，在紫杉醇输注期间连续进行，然后在紫杉醇输注完成后 15 分钟进行，共计 90 分钟。 将使用 Elasto-gel 手套和 Rapid Relief 拖鞋进行冷冻疗法。 这些物品将在开始后 45 分钟更换，以确保寒冷。
研究将分为两个部分。 一只手臂将包括将在脚/手上穿一只拖鞋/一只手套的受试者，而另一只脚/手将作为对照。 另一只手臂将包括将对双手和双脚进行冷冻疗法的受试者。 . 该过程将与 12 剂紫杉醇一起重复总共 12 次。 在时间点 13，在对他们的肿瘤学家进行例行访问期间，受试者的指甲将随着 BPI 和 NPSIA 的完成而重新评估，每组将招募总共 25 名受试者。
研究类型
介入性
注册 (实际的)
14
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
-
-
Indiana
-
Fort Wayne、Indiana、美国、46845
- Parkview Cancer Institute
-
-
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
14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：
- 年满 18 岁的女性
- 经组织学证实的乳腺癌诊断
- 接受新辅助或辅助剂量密集型蒽环类药物 (AC) 加紫杉类化疗或紫杉醇联合曲妥珠单抗和帕妥珠单抗
排除标准：
- 先前的紫杉烷治疗
- 既往奥沙利铂治疗
- 不会说英语
- 周围神经病史，即 Buerger 病
- 糖尿病史
- 其他疾病引起的预先存在的周围神经病变，例如雷诺氏病、格林巴利综合征、米勒费雪综合征
- 手部、指甲或足部疾病，例如手/足综合症、关节炎、槌状趾、腕管、拇囊炎、畸形
- 酒精滥用（历史/当前）
- 阿片类药物、抗抑郁药、抗惊厥药、谷氨酰胺、维生素 B12 的当前药物使用情况
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：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：介入冷冻治疗/对照
受试者将拥有一只手套/一只拖鞋并作为他们自己的对照
|
将进行冷冻疗法
|
|
无干预：护理标准
受试者将有两个手套/拖鞋
|
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 |
|---|---|---|
|
麻木、刺痛、疼痛、指甲毒性
大体时间：13周
|
治疗后的手/脚没有麻木和刺痛感
|
13周
|
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：Danielle R Payne, MSN、Parkview Health
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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- Descoeur J, Pereira V, Pizzoccaro A, Francois A, Ling B, Maffre V, Couette B, Busserolles J, Courteix C, Noel J, Lazdunski M, Eschalier A, Authier N, Bourinet E. Oxaliplatin-induced cold hypersensitivity is due to remodelling of ion channel expression in nociceptors. EMBO Mol Med. 2011 May;3(5):266-78. doi: 10.1002/emmm.201100134. Epub 2011 Mar 24.
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- Elasto-Gel(2019).Elasto-Gel.Retrieved on December 1,2019 from https://www.elastogels.com/product/elasto-gel-hot-cold-therapy-mitten/
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- Griffiths C, Kwon N, Beaumont JL, Paice JA. Cold therapy to prevent paclitaxel-induced peripheral neuropathy. Support Care Cancer. 2018 Oct;26(10):3461-3469. doi: 10.1007/s00520-018-4199-9. Epub 2018 Apr 21.
- Grisold W, Cavaletti G, Windebank AJ. Peripheral neuropathies from chemotherapeutics and targeted agents: diagnosis, treatment, and prevention. Neuro Oncol. 2012 Sep;14 Suppl 4(Suppl 4):iv45-54. doi: 10.1093/neuonc/nos203.
- Hanai A, Ishiguro H, Sozu T, Tsuda M, Yano I, Nakagawa T, Imai S, Hamabe Y, Toi M, Arai H, Tsuboyama T. Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial. J Natl Cancer Inst. 2018 Feb 1;110(2):141-148. doi: 10.1093/jnci/djx178.
- Hoffman,K. (2014). Diagnosing and Treating Chemotherapy-Induced Nail Changes. Podiatry Today,27(2). Retrieved on December 16, 2019from https://www.podiatrytoday.com/diagnosing-and-treating-chemotherapy-induced-nail-changes
- Hussain S, Anderson DN, Salvatti ME, Adamson B, McManus M, Braverman AS. Onycholysis as a complication of systemic chemotherapy: report of five cases associated with prolonged weekly paclitaxel therapy and review of the literature. Cancer. 2000 May 15;88(10):2367-71. doi: 10.1002/(sici)1097-0142(20000515)88:103.0.co;2-#.
- Ishiguro H, Takashima S, Yoshimura K, Yano I, Yamamoto T, Niimi M, Yamashiro H, Ueno T, Takeuchi M, Sugie T, Yanagihara K, Toi M, Fukushima M. Degree of freezing does not affect efficacy of frozen gloves for prevention of docetaxel-induced nail toxicity in breast cancer patients. Support Care Cancer. 2012 Sep;20(9):2017-24. doi: 10.1007/s00520-011-1308-4. Epub 2011 Nov 16.
- LaPointe NE, Morfini G, Brady ST, Feinstein SC, Wilson L, Jordan MA. Effects of eribulin, vincristine, paclitaxel and ixabepilone on fast axonal transport and kinesin-1 driven microtubule gliding: implications for chemotherapy-induced peripheral neuropathy. Neurotoxicology. 2013 Jul;37:231-9. doi: 10.1016/j.neuro.2013.05.008. Epub 2013 May 24.
- Lee JJ, Swain SM. Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol. 2006 Apr 1;24(10):1633-42. doi: 10.1200/JCO.2005.04.0543.
- Kadakia KC, Rozell SA, Butala AA, Loprinzi CL. Supportive cryotherapy: a review from head to toe. J Pain Symptom Manage. 2014 Jun;47(6):1100-15. doi: 10.1016/j.jpainsymman.2013.07.014. Epub 2013 Nov 7.
- Kerckhove N, Collin A, Conde S, Chaleteix C, Pezet D, Balayssac D. Long-Term Effects, Pathophysiological Mechanisms, and Risk Factors of Chemotherapy-Induced Peripheral Neuropathies: A Comprehensive Literature Review. Front Pharmacol. 2017 Feb 24;8:86. doi: 10.3389/fphar.2017.00086. eCollection 2017.
- Kolb NA, Smith AG, Singleton JR, Beck SL, Stoddard GJ, Brown S, Mooney K. The Association of Chemotherapy-Induced Peripheral Neuropathy Symptoms and the Risk of Falling. JAMA Neurol. 2016 Jul 1;73(7):860-6. doi: 10.1001/jamaneurol.2016.0383.
- Kumar SP. Utilization of brief pain inventory as an assessment tool for pain in patients with cancer: a focused review. Indian J Palliat Care. 2011 May;17(2):108-15. doi: 10.4103/0973-1075.84531.
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- Memorial Sloan Kettering Cancer Center (2017) Nail changes during treatment with Taxane-based chemotherapy Retrieved December17,2019 from https://www.mskcc.org/pdf/cancer-care/patient-education/nail-changes-during-treatment-taxanes
- Miltenburg NC, Boogerd W. Chemotherapy-induced neuropathy: A comprehensive survey. Cancer Treat Rev. 2014 Aug;40(7):872-82. doi: 10.1016/j.ctrv.2014.04.004. Epub 2014 Apr 18.
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- Sanofi (2019).Taxotere prescribing information. Retreived on December 11, 2019 from http://products.sanofi.us/taxotere/Taxotere.html
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- Wilkinson,M., Cocilovo,C., & Schar,M. (2016) Reduction of paclitaxel neuropathy with cryotherapy.Journal of Clinical Oncology.34(suppl 3S;abst 124) retrieved on December 2,2019 from https://meetinglibrary.asco.org/record/119151/abstract
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- Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.
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)
2020年8月4日
初级完成 (实际的)
2021年2月3日
研究完成 (实际的)
2021年2月3日
研究注册日期
首次提交
2020年9月3日
首先提交符合 QC 标准的
2020年9月15日
首次发布 (实际的)
2020年9月22日
研究记录更新
最后更新发布 (实际的)
2021年3月8日
上次提交的符合 QC 标准的更新
2021年3月4日
最后验证
2021年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
将共享以下内容：去标识化后计划文章中报告的结果所依据的个人参与者数据，包括文本、表格、数字、附录
IPD 共享时间框架
发布后立即生效，没有结束日期
IPD 共享访问标准
任何出于任何目的希望访问数据的人都可以通过联系 nancy.ehmke@parkview.com 获得数据
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 知情同意书 (ICF)
- 临床研究报告（CSR）
- 解析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.