Clinical trial

Does a Regime of Manual Lymphatic Drainage Reduce the Incidence of Breast Cancer-related Lymphoedema Following Axillary Node Clearance: a Randomised Controlled Trial

Name
10/H0310/51
Description
Axillary lymph nodes are the main site of metastasis in breast cancer. If positive axillary lymph nodes are present, an axillary lymph node dissection (ALND) is usually performed. This procedure improves disease-free survival but comes with the risk of lymphoedema as a result of disrupted lymphatic channels. Breast cancer-related lymphoedema (BCRL) is associated with considerable morbidity, which is why proven measures to reduce its incidence would improve patient outcomes. We aimed to investigate whether a regime of manual lymphatic drainage and exercise, supervised by a manual lymphatic drainage therapist compared to standard care would reduce the incidence of breast cancer-related lymphoedema in patients undergoing ALND.
Trial arms
Trial start
2011-09-01
Estimated PCD
2016-01-01
Trial end
2016-01-01
Status
Completed
Treatment
Decongestive lymphatic therapy (DLT)
Manual lymphatic drainage
Arms:
Combination product
Standard Care
Arms:
Control group
Size
110
Primary endpoint
Absolute difference in arm volumes
Through study duration, approximately 36 months
Eligibility criteria
Inclusion criteria: * Patients with a new diagnosis of primary operable breast cancer * Surgery will involve axillary lymph node clearance Exclusion criteria: * Patients with recurrent breast cancer * Patients with previous axillary surgery * Patients with previous axillary radiotheraphy * Patients with previous arm/axillary pathology leading to arm volume changes
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}
Updated at
2023-12-18

1 organization

1 product

1 indication