Multifrequency bioimpedance in the early detection of lymphoedema

ISRCTN	ISRCTN48880939
DOI	https://doi.org/10.1186/ISRCTN48880939
Secondary identifying numbers	8881

Submission date: 08/10/2010
Registration date: 04/08/2011
Last edited: 13/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-at-new-way-of-detecting-early-signs-of-lymphoedema-after-breast-cancer-surgery

Contact information

Mrs Charlotte Stockton
Scientific

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

Study information

Study design	Observational multicentre cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Multifrequency bioimpedance in the early detection of lymphoedema after axillary surgery: an observational cohort study
Study objectives	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(s)	South Birmingham Research Ethics Committee, 19/03/2010, ref: 10/H1207/22
Health condition(s) or problem(s) studied	Lymphoedema in patients with breast cancer
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
Primary outcome measure	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 study start date	29/07/2010
Completion date	29/07/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 1100; UK sample size: 1100
Key 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
Key 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
Date of first enrolment	29/07/2010
Date of final enrolment	29/07/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

South Manchester University Hospital

Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospital of South Manchester (UK)
Hospital/treatment centre

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

Website	http://www.uhsm.nhs.uk
"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2015		Yes	No

Editorial Notes

13/03/2020: Internal review.
04/08/2017: Publication reference added.