Prevention of lymphoedema after clearance by external compression

ISRCTN	ISRCTN92355292
DOI	https://doi.org/10.1186/ISRCTN92355292
Secondary identifying numbers	9074

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

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-preventing-lymphoedema-after-surgery-to-remove-lymph-nodes-under-arm-place

Contact information

Mrs Charlotte Stockton
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
Email	charlotte.stockton@uhsm.nhs.uk

Study information

Study design	Multicentre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	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).
Secondary outcome measures	1. Quality of life (TOI and FACT B+4) 2. Costs of individual strategies (EQ5D utility measures) 3. Incidence of infection/lymphangitis at 2 years after surgery 4. Arm movement
Overall study start date	01/10/2010
Completion date	01/04/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned sample size: 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

England
United Kingdom

Study participating centre

University Hospital of South Manchester

Manchester
M23 9LT
United Kingdom

Sponsor information

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

Nightingale Centre and Genesis Prevention Centre
Southmoor Road
Manchester
M23 9LT
England
United Kingdom

Email	Andrew.maines@manchester.ac.uk
Website	http://www.uhsm.nhs.uk/Pages/default.aspx
"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
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

Editorial Notes

24/07/2020: No publications found.
06/07/2017: No publications found, verifying study status with principal investigator.