Prevention of lymphoedema after clearance by external compression
| ISRCTN | ISRCTN92355292 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92355292 |
| Protocol serial number | 9074 |
| Sponsor | University Hospital of South Manchester (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme |
- Submission date
- 28/10/2010
- Registration date
- 28/10/2010
- Last edited
- 24/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Mrs Charlotte Stockton
Scientific
Scientific
University Hospital of South Manchester
Nightingale Centre and Genesis Prevention Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 4040 |
|---|---|
| charlotte.stockton@uhsm.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Prevention of lymphoedema after axillary clearance by early external compression: a multicentre randomised interventional treatment trial |
| Study acronym | PLACE |
| Study objectives | The purpose of this multi-centre trial is to test the efficacy of external graduated compression garments in preventing the onset of lymphoedema 18 months after axillary node clearance for node positive breast cancer in women who develop an arm volume increase of 4-8.9% within the first six months post surgery. |
| Ethics approval(s) | NW 8 Research Ethics Committee - Greater Manchester South on 21/05/2010, ref: 10/H1003/35 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast |
| Intervention | Intervention: Application of a graduated compression garment to the affected arm together with standard management for 12 months. Control: Standard management for arm swelling (written advice, arm elevation, and massage). Total duration of trial: 12 months Follow up length: 12 months Study Entry: single randomisation 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 after axillary node clearance (assessed by perometer scanning). |
| Key secondary outcome measure(s) |
1. Quality of life (TOI and FACT B+4) |
| Completion date | 01/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 270 |
| 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. Consented to pre-surgical arm measurements by perometer and develop arm volume increases of 4 - 8.9% within 6 months after surgery 4. Willing to attend for follow-up visits per the trial schedule 5. Written informed consent to enter the PLACE trial |
| Key exclusion criteria | 1. Any patients with no 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 6. Past history of breast/chest wall radiotherapy 7. Previous axillary clearance, either unilateral or bilateral 8. Participation in another clinical trial of local therapy that may affect the results obtained in this study 9. Pregnancy |
| Date of first enrolment | 01/10/2010 |
| Date of final enrolment | 01/04/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospital of South Manchester
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/07/2020: No publications found.
06/07/2017: No publications found, verifying study status with principal investigator.
