Condition category
Cancer
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
19/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.geefhaareenkans.info

Contact information

Type

Scientific

Primary contact

Ms Corina van den Hurk

ORCID ID

Contact details

Zernikestraat 29
Eindhoven
5612 HZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR90

Study information

Scientific title

Acronym

SCALP

Study hypothesis

Not provided at time of registration

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hair loss due to chemotherapy

Intervention

Scalp cooling with various cooling times or cooling temperatures.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Efficacy and patient acceptability of scalp cooling.

Secondary outcome measures

Relation of the efficacy of scalp cooling and:
1. Prior treatment with cytostatic agents
2. Prior or parallel hormonal treatment
3. Prior radiotherapy of the scalp
4. Liver metastases and/or liver or kidney function disorder
5. Type of hair (determined by race)

Overall trial start date

25/07/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Intravenous administered docetaxel regimes
2. Age 18 years or more
3. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

260

Participant exclusion criteria

1. Boldness before the start of the study
2. Haematological malignancies with generalised haematogenic metastases (e.g. lymphoma, leukaemia and multiple myeloma) and if in those conditions chemotherapy is given with a curative intent
3. Clinical signs of scalp metastases
4. Cold sensitivity
5. Cold agglutinin disease
6. Cryoglobulinaemia
7. Cryofibrinogenaemia

Recruitment start date

25/07/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Zernikestraat 29
Eindhoven
5612 HZ
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

http://www.lumc.nl/english/start_english.html

Funders

Funder type

Charity

Funder name

Sanofi Aventis (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Comprehensive Cancer Centre, South Region (Integraal Kankercentrum Zuid) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Interzol (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation for the Support of the Care of Cancer, South Region (Stichting Ondersteuning Regionale Kankerzorg Zuid) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Mitialto Foundation (Stichting Mitialto) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

VGZ Eindhoven (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Catharinaziekenhuis Eindhoven Scientific Funds (Wetenschappelijk Fonds Catharinaziekenhuis Eindhoven) (The Netherlands)

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