LYCA: Preventive Intervention Against Lymphedema After Breast Cancer Surgery - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Number of participants with Lymphedema measured by water displacement measurement
研究概览
简要总结
This study will examine whether lymphedema after breast cancer surgery can be reduced. In a randomised controlled design the aim is to investigate whether an early intervention with progressive resistance training and close monitoring of arm swelling can reduce the incidence of lymphedema after breast cancer surgery.
详细描述
Lymphedema is a well known and much dreaded complication after breast cancer surgery. The aim in this study is to examine if lymphedema can be prevented with early progressive strength training focusing on the arm, and close monitoring of pre clinical lymphedema in the 1 year exercise period. The primary outcome is lymphedema, and secondary outcomes are pain, self-reported symptoms of swelling, sensory disturbance, physical and psychological functioning, fatigue, depression, anxiety and health related quality of life.
158 patients operated for breast cancer with axillary node dissection, will be invited from three hospitals in Denmark, Sealand (Rigshospitalet, Ringsted Hospital, and Herlev Hospital), while on the surgical wards. Two weeks later upon consent they are recruited, baseline tested and randomized to either exercise intervention or usual care control.
The exercise intervention consists of progressive resistance training, combined with a stretching programme, with a total duration of 60 minutes per session. The group attend supervised exercises twice a week and a once weekly home exercise programme of 45 to 60 minutes duration. After 20 weeks, exercises are converted to home exercises, and they are monitored by a weekly sms-service. At 12 months, follow-up measurements are taken for both groups. Lymphedema is defined as 3% limb volume change from the baseline measurement.
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
- Single (Outcomes Assessor)
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
- •invasive unilateral breast cancer
- •undergone Axillary Lymph Node Dissection (ALND), planned for Radiotherapy
- •Danish speaking
- •consent to participate and to be randomized to either study arm.
排除标准
- •have undergone primary breast reconstruction
- •distant metastases
- •physically unable to participate for any reason
- •mental illness or cognitive impairment (dementia etc.)
- •no past history of lymphedema diagnosis or treatment
- •not previously operated with axillary lymph node dissection either side
研究组 & 干预措施
exercise group
The first 20 weeks, twice-weekly 60 minute session of physical exercise supervised by the research assistant and once weekly home exercise programme is offered. The exercise intervention will consist of stretching, scar tissue mobilization and resistance exercises.
For the following 32 weeks a home-training manual specifying three times weekly training is provided. At week 26 an individual booster session will be offered. In the case of lymphedema, referral to trained lymphedema physiotherapist for evaluation of appropriate intervention is made.
干预措施: exercise (Other)
usual care control group
Receives all standard care offered from the operating hospital and rehabilitation in the municipality.
结局指标
主要结局
Number of participants with Lymphedema measured by water displacement measurement
时间窗: 12 months
Lymphedema is defined as \>3% increase in inter limb volume difference compared to baseline, measured by ml. water displaced by lowering arm into a tub of water.
次要结局
- shoulder/arm/leg strength(12 months)
- neuropathic pain(12 months)
- Self-reported, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) questionnaire.(12 months)
- patient reported pain(12 months)
- health related quality of life questionnaire(12 months)
- International Physical Activity Questionnaire (IPAQ)(baseline and 12 months)
- tissue composition by Dual Energy X-ray Apsorptiometry (DXA)(12 months)
研究者
Oksbjerg Dalton
MD PhD
Danish Cancer Society