Condition category
Cancer
Date applied
08/10/2010
Date assigned
04/08/2011
Last edited
24/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Mrs Charlotte Stockton

ORCID ID

Contact details

South Manchester University Hospital
Nightingale Centre and Genesis Prevention Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8881

Study information

Scientific title

Multifrequency bioimpedance in the early detection of lymphoedema after axillary surgery: an observational cohort study

Acronym

Study hypothesis

The purpose of this multicentre study is to test whether there is concordance between bioimpedance and perometer arm measurements and in particular, whether bioimpedance identifies patients who are developing lymphoedema at an earlier stage, before arm volume measurement by perometry shows significant increases in arm volume.

Ethics approval

South Birmingham Research Ethics Committee approved on the 19th March 2010 (ref: 10/H1207/22)

Study design

Observational multicentre cohort study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast

Intervention

Arm volume will be measured at baseline, 1, 3, and 6 monthly thereafter to 2 years, followed by annual measurements up to 5 years using perometer arm scanning and bioimpedance. Quality of Life questionnaires (FACT B+4 and EQ5D) and a lymphoedema questionnaire will be administered as baseline, 3, 6, 12, 18, 24, 36, 48 and 60 months.

Follow up length: 60 months
Study entry: registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence of lymphoedema (greater than 10% arm volume increase compared to contralateral arm) at 2 and 5 years

Secondary outcome measures

1. Comparison of multi-frequency bioimpedance with perometer measurement
2. Prediction of lymphoedema by multi-frequency bioimpedance at 24 months
3. Quality of life in each group
4. Multivariate model assessment of factors predicting lymphoedema at 24 months
5. Lymphoedema symptoms related to changes in arm volume and bioimpedance readings

Overall trial start date

29/07/2010

Overall trial end date

29/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 18 - 90 years
2. Early breast cancer (no evidence of metastatic disease by local screening procedures) scheduled to undergo axillary node clearance
3. Willing to consent to pre-surgical arm measurements by perometry and beauvericin (BEA)
4. Agreeable to follow-up for up to 5 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 1100; UK sample size: 1100

Participant exclusion criteria

1. Any patients unwilling to consent to pre-surgical baseline measurements
2. Known distant metastasis
3. Inoperable breast cancer (T4 category or distant metastasis)
4. Node negative not undergoing axillary clearance
5. Previous axillary radiotherapy or clearance
6. Past history of breast / chest wall radiotherapy
7. Previous axillary clearance; either uni- or bi-lateral
8. Pregnancy
9. External pacemaker / defibrillator

Recruitment start date

29/07/2010

Recruitment end date

29/07/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Manchester University Hospital
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester (UK)

Sponsor details

Research and Development
Ground Floor ERC
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhsm.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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