Condition category
Cancer
Date applied
28/10/2010
Date assigned
28/10/2010
Last edited
28/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 below 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 measures

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 in each group (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 in each group

Overall trial start date

01/10/2010

Overall trial end date

01/04/2015

Reason abandoned

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

http://www.uhsm.nhs.uk/Pages/default.aspx

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes