Breast cancer, lymphoedema Cancer
Conditions
Interventions
For each of the component studies (below), the participant will be asked to attend on two principal occasions lasting no more than half a day each, and to make further shorter visits to the hospital (
will measure capillary filtration in both arms using venous occlusion plethysmography
measured pre-operatively and post-operatively, as soon as the patient is well enough to re-attend.
Study 3 ? St George?s University London
will measure lymphatic pump function on the arm on the same side as the affected breast, using a technique called lymphatic congestion lymphoscintigraphy
measured pre-operatively and post-operatively, as soon as the patient is well enough to re-attend.
Study 4 ? Brighton & Sussex Trust and GSTT - will investigate lymphovenous communica
patient?s own RBCs radio-labelled and injected back into patient
blood samples taken from both arms to assess radioactivity
measured pre-operatively and post-operatively, as soon as the patient is well enough to re-attend.
The patients undergoing Studies 1?4 will be asked to return for additional visits, l
Sponsors
St George's Healthcare NHS Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cannot be stated in numerical terms. The principal measurements are as follows: 1. Muscle lymph drainage 2. Capillary filtration rate 3. Lymphatic pump function 4. First appearance of and level of radioactivity in venous blood (as an indication of the presence and concentration of red blood cells) 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed