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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 (BCRL)

Primary Purpose

Breast Cancer Related Lymphoedema

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Decongestive lymphatic therapy (DLT)
Standard Care
Sponsored by
Norfolk and Norwich University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Related Lymphoedema focused on measuring Breast Cancer, Lymphoedema, Manual lymphatic drainage, Decongestive lymphatic therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Combination product

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patients adherence to the protocol stated exercises for 3 months post surgery
The patient's acceptability of physiotherapy exercises will be sought via questionnaires

Full Information

First Posted
September 23, 2020
Last Updated
October 6, 2020
Sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04582565
Brief Title
Manual Lymphatic Drainage Versus Standard Treatment for the Prevention of Breast Cancer-related Lymphoedema in Patients Who Undergo Axillary Node Clearance
Acronym
BCRL
Official Title
Does a Regime of Manual Lymphatic Drainage Reduce the Incidence of Breast Cancer-related Lymphoedema Following Axillary Node Clearance: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Related Lymphoedema
Keywords
Breast Cancer, Lymphoedema, Manual lymphatic drainage, Decongestive lymphatic therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group will have standard of care, consisting of verbal and written information on lymphoedema prevention and standard access to breast care nurse.
Arm Title
Combination product
Arm Type
Experimental
Arm Description
Decongestive lymphatic therapy (DLT). DLT group will involve manual lymphatic drainage with a trained manual lymphatic drainage therapist.
Intervention Type
Combination Product
Intervention Name(s)
Decongestive lymphatic therapy (DLT)
Intervention Description
Manual lymphatic drainage
Intervention Type
Other
Intervention Name(s)
Standard Care
Primary Outcome Measure Information:
Title
Absolute difference in arm volumes
Description
The primary outcome was the absolute difference in arm volumes between the affected and the contralateral arms.
Time Frame
Through study duration, approximately 36 months
Secondary Outcome Measure Information:
Title
Patients adherence to the protocol stated exercises for 3 months post surgery
Description
The patient's acceptability of physiotherapy exercises will be sought via questionnaires
Time Frame
Through study duration, approximately 36 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR47UY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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