An investigation into the pathophysiology of breast cancer-related lymphoedema

Not Applicable

Completed

• Conditions: Breast cancer, lymphoedema; Cancer

• Registration Number: ISRCTN36306656
• Lead Sponsor: St George's Healthcare NHS Trust (UK)

Brief Summary

1. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25491189 [Study 1] (added 26/11/2019) 2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25480305 [Study 4/4a] (added 26/11/2019) 3. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25727718 [Study 1] (added 26/11/2019) 4. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27309032 [Study 3] (added 26/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-12-31
• Study Start: 2014-01-07
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

1. Recent diagnosis of breast cancer
2. Surgery or radiotherapy not commenced
3. Scheduled for axillary node excision
4. No other medical condition which will interfere with research procedures
5. Age range 18?77 years
6. (4a only) History of breast cancer, at least 3 years post breast cancer surgery, with lymphoedema of the arm on the side of the cancer treatment
7. (4a only) History of breast cancer, at least 3 years post breast cancer surgery, with no lymphoedema of the arm

Exclusion Criteria

1. Previous axillary surgery
2. Previous diagnosis of breast cancer, excepting ductal carcinoma in situ
3. Prior history of lymphoedema
4. Cardiovascular disease (excluding patients with simple hypertension)

1-3 does not apply to patients attending for Study 4a

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Cannot be stated in numerical terms. The principal measurements are as follows:<br> 1. Muscle lymph drainage<br> 2. Capillary filtration rate<br> 3. Lymphatic pump function<br> 4. First appearance of and level of radioactivity in venous blood (as an indication of the presence and concentration of red blood cells)<br><br> The patients will be studied pre-operatively and post-operatively (2-4 weeks after their operation) and they will then be followed up annually for clinical examination of the arms for 3 years after their operation.<br>

Secondary Outcome Measures

Name	Time	Method
Venous pressure: this will be no higher on the side of the cancer treatment than in the opposite arm. The patients will be studied pre-operatively and post-operatively (2-4 weeks after their operation) and they will then be followed up annually for clinical examination of the arms for 3 years after their operation.