The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema: A Pragmatic, Randomized, Multicenter Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Lymphedema-specific Quality of Life (QoL) at 15 months
研究概览
简要总结
Title:
The LYMPH Trial - Microsurgical versus Conservative Therapy for Breast Cancer-Related Lymphedema
Purpose of the Study:
The LYMPH trial compares two treatments for chronic breast cancer-related lymphedema (BCRL)-a condition where fluid builds up and causes swelling, usually in the arm, after breast cancer treatment.
The study is testing whether microsurgical treatments (lymphatic surgery) are more effective than the current conservative therapy (called CDT) in improving quality of life for women with this condition.
What is BCRL? After surgery or radiotherapy for breast cancer, some women develop swelling in the arm (lymphedema) due to damaged lymphatic vessels. This condition can cause pain, heaviness, infections, reduced mobility, and emotional distress. It can also impact daily activities and work life.
Treatment Approaches:
Conservative Decongestion Therapy (CDT):
Includes manual lymphatic drainage (massage), compression bandaging/garments, skin care, and exercise.
It is currently the standard treatment, but it's time-consuming, lifelong, and does not cure the condition.
Microsurgical Treatment:
Lymphovenous Anastomosis (LVA): Creates tiny bypasses between lymphatic vessels and veins to drain excess fluid.
Vascularized Lymph Node Transfer (VLNT): Transfers healthy lymph nodes to the affected area to help restore drainage.
Sometimes liposuction is added to remove built-up fat caused by long-term lymphedema.
These surgeries aim to fix the underlying problem, not just manage the symptoms.
How the Study Works:
Participants:
280 women aged 18 or older who have had breast cancer and suffer from chronic BCRL.
Groups:
Participants are randomly assigned to one of two groups:
Group A: Receives lymphatic surgery. Group B: Continues with CDT.
Follow-Up:
All participants are followed for 2 years, with some follow-up continuing for up to 10 years. They complete questionnaires about quality of life, pain, arm swelling, and daily impact.
Crossover Option:
After the main follow-up (15 months), women in the CDT group may choose to switch to surgical treatment.
Goals and Benefits:
The main goal is to see whether women who have surgery report better quality of life than those who continue with CDT.
Other goals include measuring pain, arm swelling, infections, and the impact on daily life and costs.
This study also hopes to support broader access to lymphatic surgery, as many health insurers currently do not cover it.
Safety and Ethics:
All treatments are already used in clinical practice.
Risks of surgery (like infection or bleeding) are rare and manageable.
The study meets international ethical and safety standards.
Where is the Study Taking Place? The study is being carried out in more than 30 hospitals across Europe, North and South America, and Asia, including Belgium.
Why This Matters:
Chronic BCRL can have a serious impact on daily life and emotional well-being. By comparing two valid treatment options in a high-quality scientific study, this trial hopes to identify the most effective and sustainable way to help women live better after breast cancer.
详细描述
Background and Rationale
Breast cancer-related lymphedema (BCRL) is a common and chronic condition resulting from damage to the lymphatic system during breast cancer treatment (e.g., sentinel lymph node biopsy, axillary lymph node dissection, or radiotherapy). It can cause persistent arm swelling, pain, limited mobility, recurrent infections (such as erysipelas), and diminished quality of life (QoL).
The current standard of care, conservative complex physical decongestion therapy (CDT), is purely symptomatic, lifelong, and often ineffective in halting disease progression. CDT includes manual lymphatic drainage (MLD), compression therapy, skin care, and exercise. While beneficial, it does not address the underlying pathophysiology.
In contrast, microsurgical treatments such as lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) aim to restore lymphatic drainage. LVA involves connecting lymphatic vessels to small veins to bypass damaged areas, while VLNT introduces healthy lymph nodes into the affected area to re-establish lymphatic pathways. These procedures are promising but lack robust, multicenter randomized controlled trial (RCT) evidence to support their widespread adoption or reimbursement. The LYMPH Trial is designed to fill this critical evidence gap.
Study Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Patients ≥ 18 years of age.
- •Previous diagnosis of breast cancer.
- •Clinical diagnosis of chronic BCRL, persisting for more than 3 months, classified as
- •≥ Stage 1 (see Appendix 6B), according to ISL Minimum of 3 months CDT.
- •Ability to complete the QoL questionnaires.
- •Willingness to undergo surgery
排除标准
- •No indication for lymphatic surgery according to clinical judgment of the treating surgeon (individual reasons will be specifically documented).
- •Primary congenital LE or non-BCRL.
- •Previous surgical BCRL treatment on the side intended for intervention. General Following the pragmatic trial design and standard of care, pregnant women will not be excluded per se from study participation and will be handled according to the local standard of care.
结局指标
主要结局
Lymphedema-specific Quality of Life (QoL) at 15 months
时间窗: 15 months after randomization
Change in lymphedema-specific quality of life from baseline to 15 months post-randomization, measured using the Lymph-ICF-UL questionnaire (Upper Limb Module). This validated patient-reported outcome measure assesses impairments in function, activity limitations, and participation restrictions due to upper limb lymphedema across five domains: physical function, mental function, household activities, mobility, and life/social activities. Each of the 29 items is scored on a visual analogue scale (0-10), with higher scores indicating greater disability.
Lymphedema-specific Quality of Life (QoL) at 15 months
时间窗: 15 months after randomization
Change in lymphedema-specific quality of life from baseline to 15 months post-randomization, measured using the Lymph-ICF-UL questionnaire (Upper Limb Module). This validated patient-reported outcome measure assesses impairments in function, activity limitations, and participation restrictions due to upper limb lymphedema across five domains: physical function, mental function, household activities, mobility, and life/social activities. Each of the 29 items is scored on a visual analogue scale (0-10), with higher scores indicating greater disability.
次要结局
- Quality of Life - LYMPH-Q(Baseline, 3, 6, 9, 15, 24 months)
- Frequency of Lymphatic Drainage Sessions(Cumulative at 3, 6, 9, 15, and 24 months)
- Surgical Complications(From surgery to 24 months (surgical arm only))
- Pain Level(Baseline, 3, 6, 9, 15, 24 months)
- Arm Volume Measurement(Baseline, 3, 6, 9, 15, 24 months)
- Quality of Life (Additional Time Points)(3, 6, 9, and 24 months post-randomization)
- Generic Quality of Life - EQ-5D-5L(Baseline, 3, 6, 9, 15, 24 months)
- Burden on Patients(Cumulative from baseline to 24 months)
- Frequency of Lymphangitic Events(From randomization to 24 months)
- Quality of Life (Additional Time Points)(3, 6, 9, and 24 months post-randomization)
- Quality of Life - LYMPH-Q(Baseline, 3, 6, 9, 15, 24 months)
- Generic Quality of Life - EQ-5D-5L(Baseline, 3, 6, 9, 15, 24 months)
- Pain Level(Baseline, 3, 6, 9, 15, 24 months)
- Arm Volume Measurement(Baseline, 3, 6, 9, 15, 24 months)
- Frequency of Lymphatic Drainage Sessions(Cumulative at 3, 6, 9, 15, and 24 months)
- Frequency of Lymphangitic Events(From randomization to 24 months)
- Surgical Complications(From surgery to 24 months (surgical arm only))
- Burden on Patients(Cumulative from baseline to 24 months)