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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

NCT ID: NCT04582565

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-01-31

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.

Conditions

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Breast Cancer Related Lymphoedema

Keywords

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Breast Cancer Lymphoedema Manual lymphatic drainage Decongestive lymphatic therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

Combination product

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

Group Type EXPERIMENTAL

Decongestive lymphatic therapy (DLT)

Intervention Type COMBINATION_PRODUCT

Manual lymphatic drainage

Interventions

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Decongestive lymphatic therapy (DLT)

Manual lymphatic drainage

Intervention Type COMBINATION_PRODUCT

Standard Care

Intervention Type OTHER

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
Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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10/H0310/51

Identifier Type: -

Identifier Source: org_study_id