Scalp cooling: a randomised trial to assess the efficacy and comfort of two forms of scalp cooling in breast cancer patients who are receiving FEC chemotherapy
| ISRCTN | ISRCTN61464239 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61464239 |
| Secondary identifying numbers | N0254119954 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms R Hockney
Scientific
Scientific
The Ipswich Hospital NHS Trust
Clinical Oncology
Heath Road
Ipswich
IP4 5PD
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 | Scalp cooling: a randomised trial to assess the efficacy and comfort of two forms of scalp cooling in breast cancer patients who are receiving FEC chemotherapy |
| Study objectives | To assess the efficacy and comfort of the Paxman scalp cooler versus the Penguin cold cap system. To evaluate patients' views and response to scalp cooling and to provide health care professionals with informed research of the benefits of scalp cooling and the appropriate device. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Breast |
| Intervention | Randomised controlled trial to compare Paxman scalp cooler versus the Penguin cold cap system |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 02/01/2003 |
| Completion date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Sufficient hair to assess hair loss, willing to have either systems and aware of the time taken to use the scalp cooling, receiving FEC chemotherapy for breast cancer. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 02/01/2003 |
| Date of final enrolment | 01/11/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Ipswich Hospital NHS Trust
Ipswich, Suffolk
IP4 5PD
United Kingdom
IP4 5PD
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Ipswich Hospital NHS Trust
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 |
Editorial Notes
07/12/2015: no publications found on PubMed.
