Condition category
Cancer
Date applied
28/11/2013
Date assigned
07/01/2014
Last edited
11/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Peter Mortimer

ORCID ID

Contact details

Clinical Sciences
St George’'s
University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/H0701/112 (Protocol no. 8)

Study information

Scientific title

An investigation into the pathophysiology of Breast Cancer-Related Lymphoedema: a prospective non-randomised study

Acronym

BCRL

Study hypothesis

To investigate the pathophysiology of BCRL of the arm, concentrating on the following questions:
1. Are some breast cancer patients more likely than others to develop BCRL following their cancer treatment, irrespective of treatment received?
2. What are the factors that contribute to this phenomenon?
3. Is the lymphatic drainage from the arms of breast cancer patients who develop lymphoedema greater than in breast cancer patients who do not develop lymphoedema?
4. Is the production of tissue fluid in the arms of breast cancer patients who later develop lymphoedema greater than in breast cancer patients who do not develop lymphoedema?
5. Is the strength of contraction of the lymphatic vessels in the arms of breast cancer patients who later develop lymphoedema weaker than in breast patients who do not develop lymphoedema?
6. Do communications exist between lymphatic vessels and veins (lymphovenous communications) in the arms to protect some breast cancer patients against lymphoedema?
7. Is the pressure raised in the veins in the arm on the side of the cancer treatment?

Ethics approval

REC: 09/H0701/112

Study design

Prospective multi-centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Breast cancer, lymphoedema

Intervention

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 (these take 15–20 minutes each).

Study 1 – GSTT, Brighton & Sussex Trust and St George’s, University of London - will measure muscle lymph drainage simultaneously in both arms with quantitative lymphoscintigraphy - measured pre-operatively and post-operatively, as soon as the patient is well enough to re-attend.

Study 2 – St George’s University London; 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 communications on the arm of the affected side; 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, lasting 15–20 minutes each, during which the arms are examined for signs of oedema and their size measured using the perometer or tape-measure (as performed on the two principal visits, described below). These visits will take place following the second principal visit, and will include a key assessment approximately 3 years after the surgery. Relevant findings will be communicated to the lymphoedema clinic.

Study 4a – GSTT; will investigate lymphovenous communications on the arm of the affected side in women with and without breast cancer-related lymphoedema; patient’s own RBCs are radio-labelled and injected back into the patient; blood samples taken from both arms to assess radioactivity; investigation performed once only on patients who are at least 36 months post surgery.

Venous function will be assessed for all patients at all three sites. This is done pre-op only, except in Study 4 (also at post-op and 36 months).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

04/08/2010

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

240

Participant 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

Recruitment start date

04/08/2010

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George’'s, University of London
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's Healthcare NHS Trust (UK)

Sponsor details

St George's Research Office
Ground Floor
Hunter Wing
St George's University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

https://www.stgeorges.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/10/2016: No publications found, verifying study status with principal investigator.