Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
15/08/2012
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

Dr Saladin Sawan

ORCID ID

Contact details

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

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

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

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

  1. 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.

Additional files

Editorial Notes