A multicentre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss

ISRCTN	ISRCTN00283877
DOI	https://doi.org/10.1186/ISRCTN00283877
Protocol serial number	NTR90
Sponsor	Leiden University Medical Centre (LUMC) (The Netherlands)
Funders	Sanofi Aventis (The Netherlands), Comprehensive Cancer Centre, South Region (Integraal Kankercentrum Zuid) (The Netherlands), Interzol (The Netherlands), Foundation for the Support of the Care of Cancer, South Region (Stichting Ondersteuning Regionale Kankerzorg Zuid) (The Netherlands), Mitialto Foundation (Stichting Mitialto) (The Netherlands), VGZ Eindhoven (The Netherlands), Catharinaziekenhuis Eindhoven Scientific Funds (Wetenschappelijk Fonds Catharinaziekenhuis Eindhoven) (The Netherlands)

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

Ms Corina van den Hurk
Scientific

Zernikestraat 29
Eindhoven
5612 HZ
Netherlands

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SCALP
Study objectives	Not provided at time of registration
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Hair loss due to chemotherapy
Intervention	Scalp cooling with various cooling times or cooling temperatures.
Intervention type	Other
Primary outcome measure(s)	Efficacy and patient acceptability of scalp cooling.
Key secondary outcome measure(s)	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)
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	260
Key inclusion criteria	1. Intravenous administered docetaxel regimes 2. Age 18 years or more 3. Written informed consent
Key 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
Date of first enrolment	25/07/2005
Date of final enrolment	31/12/2007

Zernikestraat 29

Eindhoven
5612 HZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Study website	Study website	11/11/2025	11/11/2025	No	Yes