Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/08/2015
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 Gloria Shingler

ORCID ID

Contact details

Breast Cancer Specialist Nurse Counsellor
Bedford Hospital NHS Trust
South Wing
Kempston
Bedford
MK42 9DJ
United Kingdom
+44 (0)1234 355122 ext 2041
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0040122626

Study information

Scientific title

To evaluate the effects of Manual Lymphatic Drainage on limb volume and quality of life when used in addition to standard lymphoedema therapy.

Acronym

Study hypothesis

To evaluate quality of life of patients with upper limb lymphoedema secondary to breast cancer, when Manual Lympathetic Drainage message is added to the standard Lymphoedema therapy using a quantitative validated questionnaire SF36

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

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

Condition

Cardiovascular: Lymphoedema

Intervention

Manual Lymphatic Drainage and standard lymphoedema therapy vs standard lymphoedema therapy only

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2003

Overall trial end date

15/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

A clinic list of 120 patients with 3-6 monthly appointments

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2003

Recruitment end date

15/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bedford Hospital NHS Trust
Bedford
MK42 9DJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Bedford Hospital 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

Publication citations

Additional files

Editorial Notes