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 |
| Protocol serial number | N0009176682 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Gateshead Health NHS Foundation Trust (UK), NHS R&D Support Funding (UK) |
- 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
Scientific
Gateshead Health NHS Foundation Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Feasibility and acceptability of applying compression stockings. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Gateshead Health NHS Foundation Trust
Gateshead
NE9 6SX
United Kingdom
NE9 6SX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
