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

Not Applicable

Completed

• Conditions: Breast Cancer Related Lymphoedema
• Interventions: Combination Product: Decongestive lymphatic therapy (DLT); Other: Standard Care

• Registration Number: NCT04582565
• Lead Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust

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.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2020-09-23
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-09
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination product	Decongestive lymphatic therapy (DLT)	Decongestive lymphatic therapy (DLT). DLT group will involve manual lymphatic drainage with a trained manual lymphatic drainage therapist.
Control group	Standard Care	Control group will have standard of care, consisting of verbal and written information on lymphoedema prevention and standard access to breast care nurse.

Primary Outcome Measures

Name	Time	Method
Absolute difference in arm volumes	Through study duration, approximately 36 months	The primary outcome was the absolute difference in arm volumes between the affected and the contralateral arms.

Secondary Outcome Measures

Name	Time	Method
Patients adherence to the protocol stated exercises for 3 months post surgery	Through study duration, approximately 36 months	The patient's acceptability of physiotherapy exercises will be sought via questionnaires

Trial Locations

Locations (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, Norfolk, United Kingdom