Is there a constitutional ?global? lymphatic disturbance in lymphatic function in patients who develop breast cancer-related lymphoedema (BCRL)?

Is there a constitutional ?global? lymphatic disturbance in lymphatic function in patients who develop breast cancer-related lymphoedema (BCRL)? A prospective non-randomised study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN84866416

Enrollment

Registered

2013-12-17

Start date

2011-11-30

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoedema, breast cancer Cancer Breast cancer

Interventions

Quantitative lymphoscintigraphy. All patients will undergo lymphoscintigraphy (15 patients with lymphoedema and 15 patients without lymphoedema) 1. Clean the skin and inject 0.1 ml of 99mTc- nanocoll

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Previous diagnosis of breast cancer and have undergone axillary lymph node clearance 2. Require 15 patients who have developed BCRL and 15 patients who have not developed BCRL 3. No other medical condition which will interfere with research procedures 4. Age range 30-80 years

Exclusion criteria

Exclusion criteria: 1. Male participants 2. Outside age range of 30-80 years 3. Patients receiving vasoactive medication, or any other drugs known to impact on lymphatic function 4. Patients unable to give informed consent 5. Patients attempting to become pregnant or not practising any form of effective contraception 6. Cardiovascular disease (excluding patients with simple hypertension and not on any of the above drugs)

Design outcomes

Primary

Measure	Time frame
Using quantitative lymphoscintigraphy to establish if there is a disturbance in lower limb lymphatics in patients who have developed breast-cancer related lymphoedema (BCRL) and comparing this with patients who have not developed BCRL after axillary lymph node clearance surgery. The patients only attend once, which is for the scan (lymphoscintigraphy). The scan takes a total of 3 hours to complete.	—

Measure

Time frame

Using quantitative lymphoscintigraphy to establish if there is a disturbance in lower limb lymphatics in patients who have developed breast-cancer related lymphoedema (BCRL) and comparing this with patients who have not developed BCRL after axillary lymph node clearance surgery. The patients only attend once, which is for the scan (lymphoscintigraphy). The scan takes a total of 3 hours to complete.

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026