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

NCT04582565 | Completed

• 1 other identifier: 10/H0310/51
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Related Lymphoedema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Absolute difference in arm volumes

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

  Through study duration, approximately 36 months

Secondary Outcomes (1)

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

  Through study duration, approximately 36 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Standard Care

Combination product

EXPERIMENTAL

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

Combination Product: Decongestive lymphatic therapy (DLT)

Interventions

Decongestive lymphatic therapy (DLT) COMBINATION_PRODUCT

Manual lymphatic drainage

Combination product

Standard Care OTHER

Control group

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a new diagnosis of primary operable breast cancer
• Surgery will involve axillary lymph node clearance

You may not qualify if:

• 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

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR47UY, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 9, 2020
• Study Start: September 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 18, 2023

Record last verified: 2020-10

Locations

GB (1)