NCT06495034招募中不适用
A Randomized Controlled Study on Early Intervention of Airwave Compression Therapy to Prevent Breast Cancer-related Upper Limb Lymphedema
Shantou Central Hospital1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2023年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Incidence of lymphedema
研究概览
简要总结
This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema(BCRL).
详细描述
This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema (BCRL), hereby improving the quality of life of patients with breast cancer. Furthermore, we will perform exploratory analyses to investigate the predictive values of patient plasma cytokines to the occurrence and development of BCRL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in this clinical trial. Fully understand and be informed about the study and sign an informed consent form (ICF). Willing to follow and able to complete all test procedures;
- •Female, ≥18 years old and ≤70 years old at the time of signing the ICF;
- •Patients with unilateral breast cancer diagnosed by histopathology or cytology;
- •No distant metastasis;
- •To undergo unilateral axillary sentinel lymph node biopsy or unilateral axillary lymph node dissection;
- •Have not received any treatment for arm lymphedema;
- •No lymphangitis and other infections.
排除标准
- •Breast malignancy derived from other tumors rather than the primary breast cancer;
- •Patients with second primary tumor;
- •Contraindication to airwave compression therapy: Acute venous thrombosis; Acute inflammatory skin disease; Erysipelas; Arrhythmia; Pulmonary edema; Unstable hypertension; People with artificial pacemakers; Deep thrombophlebitis;
- •Have a history of mental illness or other reasons can not cooperate with treatment;
- •Embolism, cardiogenic edema, hepatogenic edema and the history of upper limb trauma and other related complications;
- •Patients using any medication that affects fluid or electrolyte balance.
结局指标
主要结局
Incidence of lymphedema
时间窗: 18 months
Incidence of lymphedema of ipsilateral upper limb
次要结局
- Quality of life assessment(18 months)
- Symptoms(18 months)
研究者
Si-Qi Qiu
Principal Investigator
Shantou Central Hospital
研究点 (1)
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