Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)
研究概览
简要总结
Phase 1: The investigators will conduct a prospective study to quantify the association between axillary web syndrome (AWS) and metastatic disease and chronic morbidities such as lymphedema, shoulder dysfunction, and pain comparing women (i) with AWS and (ii) without AWS in two cohorts of women. (n=200) Phase 2: This is a randomized controlled trial to 1) quantify the effects of (i) physical therapy compared to (ii) a control group in individuals with AWS following breast cancer surgery related to physical activity and physical impairments such as lymphedema, shoulder motion, function, and pain (n=44, 22 in each group). Funding to progress to Phase 2 of this trial has been obtained. It is anticipated 120 subjects participating in Phase 1 will be screened for eligibility for Phase 2 (separate consent and eligibility from Phase 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Patients (female or male) with a tissue diagnosis of non-invasive or invasive breast cancer
- •Planned surgical breast cancer treatment (lumpectomy or mastectomy) with a minimum removal of one axillary lymph node by sentinel node biopsy. Contralateral prophylactic mastectomy or bilateral mastectomy is allowed.
- •Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
排除标准
- •Patients (patients unable to travel easily to the University of Minnesota Medical Center for post-surgery visits).
- •Synchronous bilateral breast cancer
- •Presence of a medical complication that would prevent the patient from being able to participate in the study, such as terminal cancer
- •Previous history of upper extremity deep vein thrombosis
- •Breast cancer surgery without lymph node removal
结局指标
主要结局
Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)
时间窗: 1 Year
Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not)
Treatment Effects
时间窗: 1 Year
Range of motion (ROM) will be measured using a standard goniometer
次要结局
- Abduction range of motion (ROM)(1 month)
- Body mass index (BMI)(1 month)
- Function(1 Year)
- Physical activity(1 Year)
- Axillary web syndrome status(1 Year)
- DASH Score(1 Month)
- Pain level(1 Year)
- Lymphedema(1 Year)
- Preoperative AWS and a positive lymph node status(1 Year)