Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
21/09/2012
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

Mrs J E Todd

ORCID ID

Contact details

Macmillan Lymphodema Specialist Office
Cookridge Hospital
Leeds Teaching Hospitals NHS Trust
Hospital Lane
Leeds
LS16 6QB
United Kingdom
+44 (0)113 3924352
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130486

Study information

Scientific title

Acronym

Study hypothesis

To compare the incidence of lymphoedema development in breast cancer patients undertaking graded postoperative arm exercise compared to standard early full range shoulder exercise.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lymphoedema postmasectomy

Intervention

Randomised controlled trial
Random allocation to:
1. Graded post-operative arm exercise
2. Standard early full range shoulder exercise

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Height
2. Weight
3. Limb volume
4. Truncal oedema
5. Range of movement at the gleno-humeral joint
6. Arm swelling
7. Truncal swelling
8. Measurement of shoulder mobility

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients admitted for unilateral mastectomy and axillary node clearance who have been treated by the Breast Surgeons at Leeds General Infirmary (LGI).

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2003

Recruitment end date

30/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Macmillan Lymphodema Specialist Office
Leeds
LS16 6QB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Leeds Teaching Hospitals NHS Trust (UK)

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.sciencedirect.com/science/article/pii/S0031940608001132

Publication citations

Additional files

Editorial Notes