Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Completed All Study Visits
研究概览
简要总结
This study will be a 4 to 6 week randomized, controlled, assessor blinded, trial comparing a negative pressure massage device (intervention group), to the standard manual lymph drainage massage (control group), in breast cancer patients with chronic upper extremity lymphedema.
详细描述
Lymphedema (LE) is a protein-rich interstitial swelling caused by reduced lymph transport secondary to lymphatic system damage from cancer treatments. 1 in 5 women will develop LE following breast cancer treatment. These women have greater restrictions in activity and poorer quality of life (QOL) and are more prone to cellulitis than women without LE. LE is incurable and progressive. Persistent lymph stasis creates a condition of chronic inflammation that contributes to fibrosis and fatty deposition in the subcutis of the affected limb. The fibro-adipose changes associated with chronic LE make it less responsive to treatments that primarily target limb volume. Treatments are needed that can improve these skin and subcutaneous tissues changes, as well as reduce limb volume.
This 4 to 6 week randomized controlled pilot feasibility study will enroll 80 women with chronic arm LE, and will evaluate a novel negative pressure massage device that mobilizes skin and subcutaneous tissue. This negative pressure treatment provides vertical (lifting) and horizontal stretching of the skin and underlying fascial structures, which increases the subcutaneous space for lymphatic circulation, improves lymph flow, and has the potential to decrease fibrosis. This treatment will be compared to the standard of care massage: manual lymphatic drainage. Women will be randomly assigned to either the negative pressure massage device (intervention group), to the standard manual lymph drainage massage (control group)
Objectives: To evaluate recruitment and retention rates; to determine rates of adverse events; and to determine effect sizes for limb volume, tissue induration; and patient reported outcomes of arm function, QOL, and body image in response to treatment
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
- Single (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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants Who Completed All Study Visits
时间窗: At 4 weeks
Retention rates for both arms of this study were evaluated. The numbers of women who completed the study will be recorded. Reasons for drop out will be ascertained.
Recruitment Rates
时间窗: At 4 weeks
The recruitment rate is defined as the number of women who were screened and then enrolled on the study divided by the the total number of women screened overall.
次要结局
- Mean L-DEX® Scores(At 4 weeks)
- Mean Skin Induration Score(At 4 weeks)
- Mean Lymphedema Index (L-DEX®) Ratio Scores(At Baseline)
- Mean Limb Volume(At 4 weeks)
- Mean Degrees of Shoulder Range of Motion(At 4 weeks)
- Mean Body Image Scale (BIS) Score(At 4 weeks)
- Mean Self-Administered Comorbidity Questionnaire (SCQ) Scores(4 weeks)
- Mean Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) Scores(At 4 weeks)
- Mean Karnofsky Performance Status (KPS) Score(At 4 weeks)
- Mean Norman Questionnaire (NQ) Scores(At 4 months)
- Mean Disability of Arm, Shoulder, Hand Questionnaire (DASH) Scores(At 4 weeks)
- Mean Grip Score(At 4 weeks)
- Mean Patient-Reported Outcomes Measurement Information System® (PROMIS) Physical Function for the Upper Extremity (UE)(At 4 weeks)
- Mean Scores on the Participant Version of the Patient-Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2)(At 4 weeks)
- Mean Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores(At 4 weeks)