Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04582565 |
| Other study ID # |
10/H0310/51 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2011 |
| Est. completion date |
January 2016 |
Study information
| Verified date |
October 2020 |
| Source |
Norfolk and Norwich University Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
