A multicentre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss
ISRCTN | ISRCTN00283877 |
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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
Contact information
Ms Corina van den Hurk
Scientific
Scientific
Zernikestraat 29
Eindhoven
5612 HZ
Netherlands
Study information
Study design | Multicentre, randomised, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 25/07/2005 |
Completion date | 31/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Zernikestraat 29
Eindhoven
5612 HZ
Netherlands
5612 HZ
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Website | http://www.lumc.nl/english/start_english.html |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |