Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Arm Volume
研究概览
简要总结
This research study is a Pilot Study examining the use of a compression sleeve with embedded sensor to prevent lymphedema.
详细描述
This is a single arm pilot study of a compression sleeve intervention for patients at high risk of breast cancer-related lymphedema (BCRL). The compression sleeve will also include a novel sensor to capture patient adherence to compression wear and pressure applied to the arm.
This research is being done because patients receiving lymph node surgery and lymph node radiation for breast cancer are at risk of lymphedema on the arm, trunk or breast/chest wall on the side of treatment. There is some evidence that compression sleeves may prevent progression of early swelling to lymphedema. This study is looking to determine if:
- a compression garment worn for four weeks helps to prevent breast cancer-related lymphedema (BCRL) in those at high risk of BCRL
- a sensor attached to the sleeve is accurately measuring time worn and pressure applied
- participants are wearing the compression for the prescribed time, and if not, what are the barriers to wear
- participants adhere to the study schedule for filling out patient surveys regarding symptoms and satisfaction with screening.
Findings from this study will apply to the development of a larger randomized controlled trial to examine if compression prevents progression to BCRL for patients with low volume swelling.
Study procedures include screening for eligibility, treatment including evaluations and follow up visits. Study treatment will last for four weeks with follow up at one, three, six, nine and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Eligible participants will be female, >/= 18 years, who underwent BC surgery for invasive or in-situ carcinoma with unilateral axillary lymph node dissection (ALND) (with or without contralateral prophylactic SLNB). Because of the extremely low incidence of BC in children and males, only female participants over the age of 18 will be included.
- •Eligible participants will demonstrate low volume swelling (RVC 5-<10%) >/=12 weeks postoperatively
- •Eligible participants will read and comprehend English, with the ability to understand and the willingness to sign a written consent document.
- •Most patients treated for breast cancer will have undergone SLNB for axillary staging, and are therefore at lower risk for BCRL, compared to patients with ALND and/or regional lymph node radiation (RLNR). We have chosen to include only patients at high risk of BCRL, i.e., those who have undergone ALND, and we will not be including those who are at low BCRL risk, i.e., had only SLNB for axillary staging on the side of BC.
排除标准
- •Participants who have bilateral BC (ie. contralateral staging SLNB or ALND) will not be eligible due to the need of a contralateral control arm for the RVC equation.
- •Participants will not be eligible if they have been diagnosed and/or treated for BCRL.
- •Participants will not be eligible if they have metastases that may cause BCRL. Participants with metastatic disease will be excluded.
- •Participants with implanted cardiac devices and those who are pregnant will be excluded from the Sozo measurement component of the study.
研究组 & 干预措施
Compression therapy
Participants will receive a ready to wear compression sleeve and glove with embedded sensor.
Compression sleeve will be set to 20-30mm Hg pressure with instructions to wear for 12 hours a day for four consecutive weeks.
Participants will also receive a journal to record usage and standard of care post-operative lymphedema monitoring and education and asked to fill out questionnaires.
干预措施: Juzo Compression Sleeve and Glove (Device)
Compression therapy
Participants will receive a ready to wear compression sleeve and glove with embedded sensor.
Compression sleeve will be set to 20-30mm Hg pressure with instructions to wear for 12 hours a day for four consecutive weeks.
Participants will also receive a journal to record usage and standard of care post-operative lymphedema monitoring and education and asked to fill out questionnaires.
干预措施: Compression Sleeve Sensor (Device)
结局指标
主要结局
Arm Volume
时间窗: 1, 3, 6, 9 and 12 months
Primary objective is efficacy of compression intervention to change rate of progression from low volume swelling (LVS) (relative volume change (RVC) 5-\<10%) to breast cancer-related lymphedema (BCRL) (RVC \>/=10%). Measurement of effect of the compression intervention will be completed with arm volume measurements using perometry (infrared optical electronic scanner) .
次要结局
- Sensor Accuracy(4 Weeks)
- Adherence rate to compression(4 Weeks)
- Questionnaire Completion(1, 3, 6, 9 and 12 months)
研究者
Alphonse Taghian
Principal Investigator
Massachusetts General Hospital