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 |
| Protocol serial number | N0254119954 |
| Sponsor | Department of Health (UK) |
| Funder | Ipswich Hospital NHS Trust |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| 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
- United Kingdom
- England
Study participating centre
The Ipswich Hospital NHS Trust
Ipswich, Suffolk
IP4 5PD
United Kingdom
IP4 5PD
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/12/2015: no publications found on PubMed.
