A Pilot Randomized Trial Comparing Arm Circumference and Bioimpedance Measurement for Early Detection and Treatment of Lymphedema in Patients Undergoing Axillary Lymph Node Dissection or Sentinel Node Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Rates of Enhanced Lymphedema Detection
研究概览
简要总结
This randomized pilot clinical trial studies arm circumference measurement with or without bioimpedance spectroscopy in finding extra lymph node fluid build up in the arm (lymphedema) early in patients with stage I-III breast cancer undergoing lymph node dissection or sentinel node biopsy. Diagnostic procedures, such as bioimpedance spectroscopy, may allow doctors to find and diagnose lymphedema earlier than arm circumference measurement alone.
详细描述
PRIMARY OBJECTIVES:
I. To test, in a randomized controlled trial, the ability of the enhanced lymphedema (LE) detection program (ELED) versus arm circumference alone to detect early/reversible LE.
II. To compare the severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, between the two detection modalities.
III. To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement/bioimpedance spectroscopy (BIS) difference.
IV. To compare the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment between the enhanced vs. standard detection groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with stage I-III cancer of the female breast
- •Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy as well as before surgery
- •Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy as well as before surgery
- •Patients with a history of other invasive malignancies are eligible as long as they have no evidence of disease 5 years post-diagnosis
- •Patients with basal cell and squamous cell cancer of the skin are eligible
- •Patients willing to return to the study site for the duration of the study (34 months)
排除标准
- •Pregnant women
- •Patients who are homebound or dependent upon a walker or wheelchair for mobility
- •Patients diagnosed enhanced lymphedema
- •Hypertensive patients who are using diuretics
- •Documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
- •Prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer
研究组 & 干预措施
Standard LE detection
Arm measurements taken. Patients undergo arm circumference measurement at 4, 10, 16, 22, 28, and 34 months.
干预措施: arm circumference measurement (Procedure)
Enhanced LE detection
Bioimpedance spectroscopy used along with arm measurements. Patients undergo arm circumference measurement and bioimpedance spectroscopy at 4, 10, 16, 22, 28, and 34 months.
干预措施: arm circumference measurement (Procedure)
Enhanced LE detection
Bioimpedance spectroscopy used along with arm measurements. Patients undergo arm circumference measurement and bioimpedance spectroscopy at 4, 10, 16, 22, 28, and 34 months.
干预措施: Bioimpedance spectroscopy (Device)
结局指标
主要结局
Rates of Enhanced Lymphedema Detection
时间窗: During treatment (Up to 34 months)
Rates of enhanced lymphedema detection will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models. \*\*\* Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.\*\*\*
次要结局
- Severity of Enhanced Lymphedema(During treatment (Up to 34 months))
- Percentage of Subjects With Complete Resolution of Signs of Enhanced Lymphedema(During treatment (up to 34 months) plus 1 year post treatment)