Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0009176682
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Feasibility and acceptability of applying compression stockings.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
29/12/2005
Overall trial end date
01/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
20 Patients diagnosed with vulvar cancer of at least FIGO stage 1A.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
20
Participant exclusion criteria
All patients diagnosed with vulval cancer greater than stage 1A.
Recruitment start date
29/12/2005
Recruitment end date
01/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gateshead Health NHS Foundation Trust
Gateshead
NE9 6SX
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Gateshead Health NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (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. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19955953
Publication citations
-
Results
Sawan S, Mugnai R, Lopes Ade B, Hughes A, Edmondson RJ, Lower-limb lymphedema and vulval cancer: feasibility of prophylactic compression garments and validation of leg volume measurement., Int. J. Gynecol. Cancer, 2009, 19, 9, 1649-1654, doi: 10.1111/IGC.0b013e3181a8446a.