Manual Lymphatic Drainage Versus Standard Treatment for the Prevention of Breast Cancer-related Lymphoedema in Patients Who Undergo Axillary Node Clearance

Study Overview
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Brief Summary
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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.

Detailed Description
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Eligible patients were those in whom a primary operable breast cancer is diagnosed and in whom surgery is planned to include ALND. Patients with recurrent carcinoma, previous axillary surgery/radiotherapy or any previous arm/axillary pathology leading to arm volume changes will be excluded. Eligible participants will be identified at the breast multidisciplinary meeting and will be informed of the study and given a written information sheet. Patients who choose to participate will be asked to fill in a written consent form. Patients allocated to the decongestive lymphatic therapy group will undergo intervention for a total period of 3 months. This will consist of 2 visits to a qualified practitioner in Dr Vodder manual lymphatic drainage therapist, one at the start of the 3-month period and again 6 weeks later. Patients in both groups will also be instructed to perform self-MLD on a daily basis and will be taught a series of exercises to be performed on a daily basis. Compression hosiery will be fitted to be worn during the exercises.

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

Conditions
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Breast Cancer Related Lymphoedema

Intervention / Treatment
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* Combination Product: Decongestive lymphatic therapy (DLT)
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Control group will have standard of care, consisting of verbal and written information on lymphoedema prevention and standard access to breast care nurse. | Other: Standard Care<br> <br> |
| Experimental: Combination product<br>Decongestive lymphatic therapy (DLT). DLT group will involve manual lymphatic drainage with a trained manual lymphatic drainage therapist. | Combination Product: Decongestive lymphatic therapy (DLT)<br>* Manual lymphatic drainage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute difference in arm volumes | The primary outcome was the absolute difference in arm volumes between the affected and the contralateral arms. | Through study duration, approximately 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients adherence to the protocol stated exercises for 3 months post surgery | The patient's acceptability of physiotherapy exercises will be sought via questionnaires | Through study duration, approximately 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Lymphoedema, Manual lymphatic drainage, Decongestive lymphatic therapy