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

Norfolk and Norwich University Hospitals NHS Foundation Trust

Status: Completed

Conditions: Breast Cancer Related Lymphoedema

Treatments: Combination Product: Decongestive lymphatic therapy (DLT); Other: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04582565

10/H0310/51

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: Under 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Control group

Active Comparator group

Description:

Control group will have standard of care, consisting of verbal and written information on lymphoedema prevention and standard access to breast care nurse.

Treatment:

Other: Standard Care

Combination product

Experimental group

Description:

Decongestive lymphatic therapy (DLT). DLT group will involve manual lymphatic drainage with a trained manual lymphatic drainage therapist.

Treatment:

Combination Product: Decongestive lymphatic therapy (DLT)