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Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

2020年5月28日 更新者：Navid Toyserkani、Odense University Hospital
Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-derived stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.

研究概览

地位

未知

条件

干预/治疗

详细说明

Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-deried stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.

Investigators plan to include 10 patients with unilateral lymphedema after previous breast cancer treatment

研究类型

介入性

注册 (预期的)

10

阶段

  • 阶段2
  • 阶段1

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

  • 丹麦
      • Odense、丹麦、5000
        • Odense University Hospital

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 至 70年 (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

Inclusion Criteria:

  1. Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
  2. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
  3. The opposite upper extremity is healthy.
  4. ASA score of 1 or 2.
  5. The patient is able to read, understand, and complete Danish questionnaires.
  6. Lymphedema grade 1 or 2. A minimum circumference distance of 2cm on either lower or upper arm.

Exclusion Criteria:

  1. The patient is pregnant or lactating.
  2. The patient has bilateral lymphedema of the upper extremities.
  3. The patient has or has had other malignancies other than breast cancer.
  4. The patient is treated with anti-diabetic medication.
  5. The patient is diagnosed with any form of psychotic disorder.
  6. The patient is smoking.

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：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment
Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction
程序：Cell-assisted lipotransfer
Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)

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
Change in arm volume
大体时间：Baseline, 1, 3, 6, 12 and 48 months
Assessed by clinical measurements
Baseline, 1, 3, 6, 12 and 48 months

次要结果测量

结果测量
措施说明
大体时间
Side effects of treatment
大体时间：1, 3, 6, 12 and 48 months
Any side effects of experimental treatment. Assessed by asking the patient at each visit. All reported findings will be reported at study completion
1, 3, 6, 12 and 48 months
Subjective change assessed LYMQOL questionnaire
大体时间：Baseline, 1, 3, 6, 12 and 48 months
Subjective change of lymphedema assessed by questionnaire
Baseline, 1, 3, 6, 12 and 48 months
Subjective change assessed DASH questionnaire
大体时间：Baseline, 1, 3, 6, 12 and 48 months
Subjective change of lymphedema assessed by questionnaire
Baseline, 1, 3, 6, 12 and 48 months
Change in lymph drainage
大体时间：Baseline and 12 months
Change in lymph drainage assessed by lymphoscintigraphy compared with preoperative lymphoscintigraphy
Baseline and 12 months
Subjective change in feeling of tension in arm assessed by numeric scale from 0-10
大体时间：Baseline, 1, 3, 6, 12 and 48 months
Feeling of tension in the arm (separately) 0=healthy and 10=worst imaginable
Baseline, 1, 3, 6, 12 and 48 months
Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10
大体时间：Baseline, 1, 3, 6, 12 and 48 months
Feeling of heaviness in the arm (separately) 0=healthy and 10=worst imaginable
Baseline, 1, 3, 6, 12 and 48 months
Change in arm volume
大体时间：Baseline, 3, 6 and 12 months
Assessed by DXA scan
Baseline, 3, 6 and 12 months
Number of arm infections
大体时间：Baseline, 1, 3, 6, 12 and 48 months
Number of arm infections needing antibiotic treatment. Assesed by asking the patient each visit.
Baseline, 1, 3, 6, 12 and 48 months
Change in conservative lymphedema treatment
大体时间：Baseline, 1, 3, 6, 12 and 48 months
Change in use or type of conservative lymphedema treatments. Assesed by asking the patient each visit.
Baseline, 1, 3, 6, 12 and 48 months

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。

赞助

Odense University Hospital

调查人员

  • 首席研究员：Navid M Toyserkani, MD、Dept. Plastic and Reconstructive Surgery, Odense University Hospital

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

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

2015年10月1日

初级完成 (预期的)

2020年9月1日

研究完成 (预期的)

2020年9月1日

研究注册日期

首次提交

2015年10月28日

首先提交符合 QC 标准的

2015年10月29日

首次发布 (估计)

2015年10月30日

研究记录更新

最后更新发布 (实际的)

2020年6月1日

上次提交的符合 QC 标准的更新

2020年5月28日

最后验证

2020年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • S-20150109

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.

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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