Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Measurement of impedances and extracellular water (ECW) ratio
研究概览
简要总结
Breast cancer is the second most common cancer in women. One in five women who have been treated for breast cancer develop lymphedema. Lymphedema is a very common result of breast cancer and its treatment. Lymphedema is the build-up of fluid in tissues, which results in tissue swelling. The lymph system is a network of lymph vessels, tissues, and organs that carry extra fluid from your cells/tissues throughout the body. If this lymph fluid is not able to flow in the body how it should, there will be swelling which can lead to lymphedema. It can be classified into stages 0 to 3 depending on the severity of the condition. Stages 0 and 1 are reversible, and through early diagnosis and treatment, the recovery to the normal volume and normal skin status of arms can be possible. On the other hand, stage 2 or higher is irreversible, and tissue fibrosis progresses and cannot return to normal skin; therefore, it is important to detect early and start treatment.
This is an observational longitudinal study. Potential participants will be recruited for follow-up after breast cancer surgery. Only patients who fit the inclusion criteria will be considered for participation in the study and contacted by the healthcare provider. Standard of care will be used to guide any treatment needed by participants while they are part of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults 18 and over who are diagnosed with unilateral breast cancer.
- •Unilateral lumpectomy, unilateral mastectomy, or simultaneous contralateral prophylatic mastectomy within 12 months of enrollment
- •Axillary lymph node dissection or sentinel node biopsy within 12 months of enrollment
- •Adjuvant or neoadjuvant chemotherapy and/or radiation therapy are allowed
- •Breast cancer reconstruction completed or planned is allowed
- •Study participants must own or have access to a smartphone, iPhone (IOS version 9.0 or above) or Android phone (Android 8.1 or above).
排除标准
- •Bilateral breast cancer
- •Previous history of breast cancer prior to current diagnosis.
- •Existing diagnosis of lymphedema at the time of enrollment
- •Cellulitis or other active infection at the time of enrollment
- •Adults who are unable to consent.
- •Pregnant women
- •Prisoners
- •Individuals under the age of 18 years old
- •Individuals who are illiterate
- •Individuals who lack the capacity to consent
- •Non-English speakers
- •Individuals with medical implant devices such as pacemakers, or essential support devices such as patient monitoring systems.
结局指标
主要结局
Measurement of impedances and extracellular water (ECW) ratio
时间窗: 3, 6, 9, and 12 months
Measurement of impedances and extracellular water (ECW) ratio between affected and unaffected sides at initial visit using the clinical and home units (InBody 770 and InBody BWA ON). Inbody BWA 770 Timeline: baseline, 3, 6, 9, 12 month Inbody BWA ON Timeline: 2x/day x 12 months
次要结局
- attitudes(12 months)
- Impact of lymphedema(baseline, 3, 6, 9, and 12 months)
- Skin/tissue assessment(baseline, 3, 6, 9, and 12 months)
- Measurement of impedances and extracellular water (ECW) ratio(3, 6, 9, and 12 months)
- Bilateral upper extremity shoulder goniometric range of motion measurements(baseline, 3, 6, 9, and 12 months)
- Disabilities(baseline, 3, 6, 9, and 12 months)
- Bilateral upper extremity girth circumference measurements(baseline, 3, 6, 9, and 12 months)