Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in arm volume
研究概览
简要总结
Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All patients undergo the same liposuction procedure. During general anesthesia, patients are randomized to either fat grafting or sham grafting with saline injection to the axilla. After stem cell suspension, patients receive either stem cell or saline injection depending on randomization using masked syringes.
Participants are blinded, care providers postoperatively are blinded, primary investigator is blinded and all outcome assessors are blinded. The surgeon performing the liposuction and the stem-cell staff are unblinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
- •Cancer free for at least 1 year
- •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 (no lymphedema).
- •ASA score of 1 or
- •The patient is able to read, understand, and complete Danish questionnaires.
- •Pitting lymphedema ISL grade 1 or
- •A minimum circumference difference of 2cm or a minimum volume difference of 200mL.
排除标准
- •Pregnant or lactating.
- •Bilateral lymphedema
- •Current or previous malignancies other than breast cancer.
- •Insulin-dependent diabetes.
- •Diagnosed with any form of psychotic disorder, which may impact study participation.
- •Not ceased smoking during treatment.
- •Active implantables (e.g. pacemaker or neurostimulator)
- •Unrealistic treatment expectations.
- •Known hepatitis, HIV or syphilis infection.
结局指标
主要结局
Change in arm volume
时间窗: Baseline, 3, 6, 9 and 12 months
Assessed using clinical circumference measurement
次要结局
- Safety of treatments: Assessed by asking the patient at each visit(Baseline, 3, 6, 9 and 12 months)
- Subjective changes assessed using the LYMPH-ICF (Lymphoedema Functioning, Disability and Health) questionaire(Baseline, 3, 6, 9 and 12 months)
- Subjective changes assessed using DASH (DISABILITIES OF THE ARM, SHOULDER AND HAND) questionaire(Baseline, 3, 6, 9 and 12 months)
- Subjective changes assessed using SF-36 questionnaire(Baseline, 3, 6, 9 and 12 months)
- Change in lymph drainage(Baseline and 12 months)
- Change in conservative lymphedema treatment(Baseline, 3, 6, 9 and 12 months)
- Change in adverse lymphedema-related events(Baseline, 3, 6, 9 and 12 months)
- Change in L-DEX score (bioimpedance)(Baseline, 3, 6, 9 and 12 months)
- Change in weight and arm tissue composition(Baseline, 3, 6, 9 and 12 months)
研究者
Mads Gustaf Jørgensen
Principal Investigator
Odense University Hospital