Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Charlotte Stockton
ORCID ID
Contact details
University Hospital of South Manchester
Nightingale Centre and Genesis Prevention Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 4040
charlotte.stockton@uhsm.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9074
Study information
Scientific title
Prevention of lymphoedema after axillary clearance by early external compression: a multicentre randomised interventional treatment trial
Acronym
PLACE
Study hypothesis
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
NW 8 Research Ethics Committee - Greater Manchester South on 21/05/2010, ref: 10/H1003/35
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/10/2010
Overall trial end date
01/04/2015
Reason abandoned (if study stopped)
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. 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned sample size: 270
Participant 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
Recruitment start date
01/10/2010
Recruitment end date
01/04/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital of South Manchester
Manchester
M23 9LT
United Kingdom
Sponsor information
Organisation
University Hospital of South Manchester (UK)
Sponsor details
Nightingale Centre and Genesis Prevention Centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
-
Andrew.maines@manchester.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
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
Basic results (scientific)
Publication list