Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in arm volume
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
- •The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
- •The opposite upper extremity is healthy.
- •ASA score of 1 or
- •The patient is able to read, understand, and complete Danish questionnaires.
- •Lymphedema grade 1 or
- •A minimum circumference distance of 2cm on either lower or upper arm.
排除标准
- •The patient is pregnant or lactating.
- •The patient has bilateral lymphedema of the upper extremities.
- •The patient has or has had other malignancies other than breast cancer.
- •The patient is treated with anti-diabetic medication.
- •The patient is diagnosed with any form of psychotic disorder.
- •The patient is smoking.
结局指标
主要结局
Change in arm volume
时间窗: Baseline, 1, 3, 6, 12 and 48 months
Assessed by clinical measurements
次要结局
- Subjective change assessed DASH questionnaire(Baseline, 1, 3, 6, 12 and 48 months)
- Change in conservative lymphedema treatment(Baseline, 1, 3, 6, 12 and 48 months)
- Side effects of treatment(1, 3, 6, 12 and 48 months)
- Subjective change in feeling of tension in arm assessed by numeric scale from 0-10(Baseline, 1, 3, 6, 12 and 48 months)
- Change in arm volume(Baseline, 3, 6 and 12 months)
- Subjective change assessed LYMQOL questionnaire(Baseline, 1, 3, 6, 12 and 48 months)
- Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10(Baseline, 1, 3, 6, 12 and 48 months)
- Number of arm infections(Baseline, 1, 3, 6, 12 and 48 months)
- Change in lymph drainage(Baseline and 12 months)
研究者
Navid Toyserkani
MD
Odense University Hospital