The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema (LYMPH)
Lymphedema, Breast Cancer
About this trial
This is an interventional treatment trial for Lymphedema, Breast Cancer focused on measuring lymphatic surgery, breast cancer related lymphedema, sentinel lymph node biopsy, axillary lymph node dissection, manual lymphatic drainage, conservative complex physical decongestion therapy
Eligibility Criteria
Inclusion Criteria: Written informed consent. Patients ≥ 18 years of age with prior treatment of breast cancer. At least one of the following prior breast cancer treatments: sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), radiotherapy (RT) of chest wall or axilla or breast cancer surgery. Clinical diagnosis of chronic BCRL as defined by the ISL (inter-limb difference of >10% in volume or excess volume between the affected and non-affected limbs present for more than 3 months). Minimum of 3 months CDT. Ability to complete the QoL questionnaires. Exclusion Criteria: No indication for lymphatic surgery according to clinical judgment of the treating surgeon (individual reasons will be specifically documented). Primary congenital LE or non-breast cancer-related LE. Need for immediate LE surgery according to clinical judgement by a specialist due to far progressed LE stage.
Sites / Locations
- University Hospital BaselRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group A : Surgical Group
Group B: Conservative Complex Physical Decongestion Therapy (control group)
According to the pragmatic study design, neither the diagnostic workup nor the surgery will be standardized in order to offer surgeons considerable leeway on how to perform lymphatic surgery, which resembles the flexibility in usual care. The key aspects of the preoperative workup and the surgery including the number of LVAs (Lymphovenous Anastomosis), harvesting of lymph nodes ("donor site"), time of surgery, and practical details will be registered.
CDT (Conservative Complex Physical Decongestion Therapy) will be performed as in usual care, following the pragmatic study design. The key aspects like frequency of lymphatic drainage, time when lymphatic drainage is performed and time and class of compressive garments are used will be documented. CDT incorporates two stages of treatment. The first treatment phase (intensive phase) entails skincare, MLD (manual lymphatic drainage), exercises aimed at improvement of mobility/range of motion in the shoulder, elbow or wrist joints, and compression therapy through bandaging. Most patients undergo this phase shortly after the diagnosis of LE. CDT in the second phase (maintenance phase) aims to maintain the achieved limb volume/ circumference reduction through compression with therapeutic elastic compression garment for the arm. Skincare, mobility exercises and MLD is continued in this phase if needed