Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Bilateral upper limb volume
研究概览
简要总结
Research purpose: Lymphedema is a very common complication in breast cancer patients. However, since there is currently no curable treatment, it is important to prevent and reduce the severity of lymphedema. The purpose of this study is to evaluate whether preoperative exercise is effective in preventing lymphedema after surgery. For secondary outcome, the preventive effects of exercise on other upper extremity dysfunctions (eg. pectoralis tightness, Axillary web syndrome, Adhesive capsulitis), which are common in breast cancer patients, were assessed.
详细描述
Study subjects:
- Patients aged 20 or older who were first diagnosed with breast cancer
- Patients scheduled to undergo neoadjuvant chemotherapy before surgery Study design: Prospective randomized controlled comparative clinical study
- Intervention is performed for at least 3 months during the neoadjuvant chemotherapy period before surgery.
- Treatment group: Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling.
- Control group: One session of flexibility exercise training, diet management education through nutritional counseling
Result variable:
- Primary outcome variable:
- Incidence and severity of postoperative lymphedema: bilateral upper limb volume, ICG lymphography
- Secondary outcome variables:
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 (Participant)
盲法说明
- Patients aged 20 or older and younger than 80 years old who were first diagnosed with breast cancer
- Patients scheduled to undergo neoadjuvant chemotherapy before surgery
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 or older and younger than 80 who were first diagnosed with breast cancer
- •Patients scheduled for surgery and starting neoadjuvant chemotherapy before surgery
排除标准
- •Patients with medical contraindications to exercise intervention or pain or musculoskeletal conditions that may limit active exercise intervention
结局指标
主要结局
Bilateral upper limb volume
时间窗: Immediately, Preoperatively, 1 month, 3 months, 6 months.
Using a tape measure, measure the circumference from the wrist to the armpit every 4cm, then apply the ΣCircumference2/π formula to calculate the volume of the upper limb.
ICG lymphography
时间窗: Immediately, 1 month, 6 months.
Indocyanine green (ICG) contrast agent is injected subcutaneously in the distal area, and lymph fluid flowing to the proximal area through collateral lymphatic vessels is checked with an infrared camera.
次要结局
- EORTC QLQ-BR23(Immediately, 6 months)
- Body composition(Immediately, 6 months.)
- Shoulder range of motion(Immediately, Preoperatively, 1 month, 3 months, 6 months.)
- Upper limb strength, grip strength(Immediately, 6 months)
- EORTC QLQ-C30(Immediately, 6 months)
研究者
Jae Yong Jeon, MD
Professor
Asan Medical Center