A Feasibility Study Evaluating Flexitouch® Plus With a Therapy Cycle Software Modification in Patients With Unilateral Breast Cancer-Related Lymphedema (BCRL)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Lymphatic Activation
研究概览
简要总结
The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female 18 years of age or older
- •Diagnosis of unilateral breast cancer-related lymphedema
- •Stage I or early stage II lymphedema without severe fibrosis at the time of enrollment
- •≥ 5% volume difference between affected and unaffected arm as verified via perometry
- •Willing and able to give informed consent
- •Willing and able to comply with the study protocol requirements and all study-related visit requirements
排除标准
- •In-home use of PCD within previous 3 months
- •Therapist or self-administered manual lymph drainage (MLD) within previous 1 week
- •Mastectomy or lymph node removal on side without lymphedema
- •Bilateral lymphedema
- •Heart failure (acute pulmonary edema, decompensated acute heart failure)
- •Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
- •Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
- •Active cancer (cancer that is currently under treatment, but not yet in remission)
- •Poorly controlled kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome
- •Any circumstance where increased lymphatic or venous return is undesirable
- •Currently pregnant or trying to become pregnant
- •Allergy to iodine
结局指标
主要结局
Lymphatic Activation
时间窗: Baseline and following a single treatment, an average of one hour
Comparison of the change in the rate of lymphatic propulsion events from the pre-treatment values to the post-treatment values for both the affected and contralateral limbs using the investigational technique of near infrared-fluorescent (NIRF) imaging.
Changes in Swelling - Perometry
时间窗: Baseline and following a single treatment, an average of one hour
Swelling in the affected and contralateral limb as assessed using local tissue water content
Changes in Swelling - MoistureMeterD
时间窗: Baseline and following a single treatment, an average of one hour
Comparison of the percent change in local tissue water from the pre-treatment values to the post-treatment values on the affected limb using MoistureMeterD.
Percent Change in Skin Thickness From Baseline to After Treatment.
时间窗: Baseline and following a single treatment, an average of one hour
Skin changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Incidence of Adverse Events
时间窗: 24-Hour Follow-Up
Adverse events reported between treatment and the 24-hour follow-up
Absolute Change in Skin Thickness From Baseline to After Treatment
时间窗: Baseline and following a single treatment, an average of one hour.
Skin Changes on the affected and contralateral limb as assessed by skin thickness (Ultrasound).
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
时间窗: Baseline and following a single treatment, an average of one hour
Comparison of the number of subjects with an increase in vessels for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging.
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging
时间窗: Baseline and following a single treatment, an average of one hour
Comparison of the change in dermal backflow from the pre-treatment values to the post-treatment values as the sum of the volume of area for all locations for both the affected and contralateral limbs via near infrared-fluorescent (NIRF) imaging
Skin Changes on the Affected and Contralateral Limb as Assessed by: Skin Thickness (Ultrasound)
时间窗: Baseline and following a single treatment, an average of one hour
Comparison of the percent of participants by arm demonstrating a decrease in thickness for each site, separating skin and subcutaneous changes, on the affected limb via Ultrasound
Swelling in the Affected and Contralateral Limb as Assessed Using: Perometry (LymphaTech 3D Scanner)
时间窗: Baseline and following a single treatment, an average of one hour
Compare the percent of participants by arm demonstrating a decrease in limb volume for the affected and contralateral limbs via Perometry (LymphaTech 3D Scanner)
次要结局
未报告次要终点