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
Secondary identifying numbers NTR90
Submission date
12/09/2005
Registration date
12/09/2005
Last edited
19/09/2008
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

Study website

Contact information

Ms Corina van den Hurk
Scientific

Zernikestraat 29
Eindhoven
5612 HZ
Netherlands

Study information

Study designMulticentre, randomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymSCALP
Study objectivesNot provided at time of registration
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedHair loss due to chemotherapy
InterventionScalp cooling with various cooling times or cooling temperatures.
Intervention typeOther
Primary outcome measureEfficacy and patient acceptability of scalp cooling.
Secondary outcome measuresRelation 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 study start date25/07/2005
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants260
Key inclusion criteria1. Intravenous administered docetaxel regimes
2. Age 18 years or more
3. Written informed consent
Key exclusion criteria1. 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 enrolment25/07/2005
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Zernikestraat 29
Eindhoven
5612 HZ
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (The Netherlands)
University/education

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

Website http://www.lumc.nl/english/start_english.html
ROR logo "ROR" https://ror.org/027bh9e22

Funders

Funder type

Charity

Sanofi Aventis (The Netherlands)

No information available

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

No information available

Interzol (The Netherlands)

No information available

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

No information available

Mitialto Foundation (Stichting Mitialto) (The Netherlands)

No information available

VGZ Eindhoven (The Netherlands)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan