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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2008 results in http://www.sciencedirect.com/science/article/pii/S0031940608001132