Night-time Compression for Breast Cancer Related Lymphedema (LYNC): A Randomized Controlled Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
研究概览
简要总结
Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.
详细描述
Lymphedema is a lifetime condition which tends to worsen over time, affecting roughly 21% of of treated breast cancer patients. An initial intensive rehabilitative treatment is usually prescribed to reduce the lymphedema, followed by a maintenance program using compression sleeves (Standard Care). However, compression sleeves are prescribed for daytime use only due to the potential tourniquet effect of the sleeve rolling up or bunching during the night.
Compression Bandages (short stretch, low elasticity) can be used at night but proper application takes 20-30 minutes, require skill to apply properly and are costly. Various types of night-compression system garments (NCSGs) have been designed as alternatives to Compression Bandages (CB).
The objectives of this study are to determine:
- Whether the addition of night-time compression (using CB or NCSG) to standard care (daytime compression only) improves control of arm lymphedema.
- Whether the use of NCSGs result in better outcomes in quality of life, sleep, treatment compliance and patient independence than use of Compression Bandages.
The hypotheses are that:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of breast cancer with mild to moderate lymphedema (minimum of 200 mls or 10% and maximum 40% increase in arm volume over the unaffected arm.)
- •Completion of all primary and adjuvant cancer treatments (with exception of endocrine treatment) 1 month prior to randomization.
- •In or entering upon the maintenance phase of lymphedema treatment.
- •Have properly fitted day-time compression sleeve and agree to wear sleeve for the 12 hour per day standard of care period
- •No current use of night-time compression (one month wash-out period before trial entry)
排除标准
- •Clinical or radiological evidence of active disease, either local or metastatic
- •History or clinical diagnosis of bilateral arm lymphedema
- •Anyone for whom compression is contraindicated, such as those with untreated infections, skin irritations/rash, or thrombosis of the affected arm
- •Serious non-malignant disease or any disorder/circumstance (psychiatric or addictive disorder) which would preclude consent/adherence to the protocol
- •Unable to comply with the protocol, measurement and follow-up schedule due to factors such as vacation during the study period
研究组 & 干预措施
Standard care
Weeks 1-12, Standard Care only (Compression Sleeve, daytime wear)
干预措施: Compression Sleeve, daytime wear (Device)
Standard Care plus Night-time Compression Bandages
Weeks 1 - 12, Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered Compression Bandages.
干预措施: Night-time compression bandages (Device)
Standard Care plus Night-time Compression Bandages
Weeks 1 - 12, Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered Compression Bandages.
干预措施: Compression Sleeve, daytime wear (Device)
Standard Care Plus Night-time Compression System Garment
Weeks 1 - 12, Standard care (day-time sleeve) plus night-time use of a custom-made Night-time Compression System Garment
干预措施: Compression Sleeve, daytime wear (Device)
Standard Care Plus Night-time Compression System Garment
Weeks 1 - 12, Standard care (day-time sleeve) plus night-time use of a custom-made Night-time Compression System Garment
干预措施: Night-time Compression custom-made garment (Device)
结局指标
主要结局
Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
时间窗: 12 weeks
次要结局
- Arm fluid. Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm(12 weeks)