Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
07/12/2015
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

Ms R Hockney

ORCID ID

Contact details

The Ipswich Hospital NHS Trust
Clinical Oncology
Heath Road
Ipswich
IP4 5PD
United Kingdom

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

07/12/2015: no publications found on PubMed.