Condition category
Cancer
Date applied
02/07/2003
Date assigned
02/07/2003
Last edited
29/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jacquelyne Todd

ORCID ID

Contact details

Lymphoedema Department
Wharfedale Hospital
Newall Carr Road
Otley
Leeds
LS21 2LY
United Kingdom
+44 (0)113 3921807
Jacquelyne.Todd@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PRF/02/1

Study information

Scientific title

A randomised comparative trial of two programmes of shoulder exercise following axillary node dissection for invasive breast cancer

Acronym

LASER (Leeds Axillary Surgery Exercise Research)

Study hypothesis

Please note that, as of 19/06/2008, this trial record was extensively amended. Most of the changes can be found in the relevant field. The following changes have also been made:
1. Scientific trial title was added
2. Study hypothesis was added
3. Anticipated end date has been updated from 31/12/2003 to 31/12/2007

Study hypothesis:
There is a reduced incidence of lymphoedema after post-operative exercise that delays full shoulder mobilisation for one week.

Ethics approval

Added as of 19/06/2008: This study was approved by the West Leeds Research Ethics Committee.

Study design

Randomised comparative trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer related lymphoedema

Intervention

Interventions amended as of 19/06/2008:
Intervention group will receive a shoulder mobilisation programme that is characterised by a delayed commencement of full range gleno-humeral exercises following the removal of the axillary drain.

Control group will receive the current standard exercise regimen which commences full range gleno-humeral exercises from the first post-operative day.

Measurements for both groups are pre-operatively and at one year, with structured telephone questionnaires at one week, one month and six months.

Previous interventions:
Intervention group will receive a shoulder mobilisation programme that is characterised by a delayed commencement of full range gleno-humeral exercises following the removal of the axillary drain.

Control group will receive the current standard exercise regimen which commences full range gleno-humeral exercises from the first post-operative day.

Measurements for both groups are pre-operatively, one month, six months and one year.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Added as of 19/06/2008:
1. Limb volume using water displacement method

Secondary outcome measures

Added as of 19/06/2008:
1. Range of movement using goniometer
2. Hand grip strength using dynamometer
3. Health related quality of life using FACTB+4, Shoulder Disability Questionnaire

Overall trial start date

01/01/2003

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who are undergoing axillary surgery followed by radiotherapy for unilateral primary breast cancer with axillary node involvement.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Added as of 19/06/2008: 104 participants (52 per group)

Participant exclusion criteria

Added as of 26/06/2008:
1. Women under eighteen years
2. Existing history of breast cancer
3. Prior axillary surgery or irradiation
4. Pre-existing lymphoedema as measured by a difference in 200 mls
between the two arms when measured pre-operatively using the volume
displacement method
5. Women requiring full time cognitive or physical care

Recruitment start date

01/01/2003

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lymphoedema Department
Leeds
LS21 2LY
United Kingdom

Sponsor information

Organisation

Physiotherapy Research Foundation (UK)

Sponsor details

The Chartered Society of Physiotherapy
14 Bedford Row
London
WC1R 4ED
United Kingdom
+44 (0)20 7306 6601
attewm@csp.org.uk

Sponsor type

Charity

Website

http://www.csp.org.uk

Funders

Funder type

Charity

Funder name

Physiotherapy Research Foundation (Ref: PRF/02/1)

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

1. 2008 results in http://www.physiotherapyjournal.com/article/S0031-9406(08)00113-2/

Publication citations

Additional files

Editorial Notes