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NCT Number: NCT04582565

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

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.

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Key information

Conditions

Breast Cancer Related Lymphoedema Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR47UY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decongestive lymphatic therapy (DLT)

Combination Product

Manual lymphatic drainage

Standard care

Other

Primary outcomes

  1. Absolute difference in arm volumes

    Time frame: Through study duration, approximately 36 months

    The primary outcome was the absolute difference in arm volumes between the affected and the contralateral arms.

Secondary outcomes

  1. Patients adherence to the protocol stated exercises for 3 months post surgery

    Time frame: Through study duration, approximately 36 months

    The patient's acceptability of physiotherapy exercises will be sought via questionnaires

Sponsors and collaborators

Lead sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: BCRL

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Oct 9, 2020
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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