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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04582565
Acronym
BCRL
Enrollment
110
Registered
2020-10-09
Start date
2011-09-30
Completion date
2016-01-31
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Related Lymphoedema

Keywords

Breast Cancer, Lymphoedema, Manual lymphatic drainage, Decongestive lymphatic therapy

Brief summary

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

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.

Interventions

COMBINATION_PRODUCTDecongestive lymphatic therapy (DLT)

Manual lymphatic drainage

OTHERStandard Care

Sponsors

Norfolk and Norwich University Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Absolute difference in arm volumesThrough study duration, approximately 36 monthsThe primary outcome was the absolute difference in arm volumes between the affected and the contralateral arms.

Secondary

MeasureTime frameDescription
Patients adherence to the protocol stated exercises for 3 months post surgeryThrough study duration, approximately 36 monthsThe patient's acceptability of physiotherapy exercises will be sought via questionnaires

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026