Multifrequency bioimpedance in the early detection of lymphoedema
| ISRCTN | ISRCTN48880939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48880939 |
| Protocol serial number | 8881 |
| Sponsor | University Hospital of South Manchester (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF) |
- 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
Contact information
Mrs Charlotte Stockton
Scientific
Scientific
South Manchester University Hospital
Nightingale Centre and Genesis Prevention Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational multicentre cohort study |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) | Incidence of lymphoedema (greater than 10% arm volume increase compared to contralateral arm) at 2 and 5 years |
| Key secondary outcome measure(s) | 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 |
| Completion date | 29/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
South Manchester University Hospital
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/03/2020: Internal review.
04/08/2017: Publication reference added.
