Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0254119954
Study information
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
Acronym
Study hypothesis
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
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: Breast
Intervention
Randomised controlled trial to compare Paxman scalp cooler versus the Penguin cold cap system
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/01/2003
Overall trial end date
01/11/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
02/01/2003
Recruitment end date
01/11/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Ipswich Hospital NHS Trust
Ipswich, Suffolk
IP4 5PD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ipswich Hospital NHS Trust
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