Feasibility Study to Investigate the Effect of Compression Stockings in the development of Lymphoedema following Treatment of Vulval Cancer

ISRCTN	ISRCTN61522748
DOI	https://doi.org/10.1186/ISRCTN61522748
Secondary identifying numbers	N0009176682

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 15/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Saladin Sawan
Scientific

Gateshead Health NHS Foundation Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	How practical and acceptable is the early use of compression stockings in vulval cancer patients after receiving treatment? This is a pilot study to investigate the feasibility of the early use of Compression Stockings in reducing the incidence and severity of lymphoedema after treatment of vulval cancer. The findings are to be used to develop a future randomised controlled trial which will be a multicentre national study.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Vulval
Intervention	Our hypothesis is that the use of compression stockings soon after treatment for vulval cancer is acceptable to patients and is worthy of investigation in the prevention of systematic lymphoedema in the form of a randomised controlled trial. Participants will be randomised using sealed envelopes into two groups: either to wear compression stockings for 6 months starting within 3 days of cancer treatment (treatment group) or not to wear them (control group). Participants in both groups will receive all the usual treatment of vulval cancer including on leg care (otherwise known as Best Supportive Care).
Intervention type	Other
Primary outcome measure	Feasibility and acceptability of applying compression stockings.
Secondary outcome measures	Not provided at time of registration
Overall study start date	29/12/2005
Completion date	01/01/2012

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	20
Key inclusion criteria	20 Patients diagnosed with vulvar cancer of at least FIGO stage 1A.
Key exclusion criteria	All patients diagnosed with vulval cancer greater than stage 1A.
Date of first enrolment	29/12/2005
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Gateshead Health NHS Foundation Trust

Gateshead
NE9 6SX
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Gateshead Health NHS Foundation Trust (UK)

No information available

NHS R&D Support Funding (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2009		Yes	No