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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR90 |
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Date of registration:
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12/07/2005 |
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Primary sponsor: |
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Public title:
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A multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss.
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Scientific title:
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A multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss. - SCALP |
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Date of first enrolment:
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3/8/2005 |
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Target sample size:
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260 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=90 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Corina
Hurk, van den |
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Address:
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Integraal Kankercentrum Zuid, sector onderzoek,
Zernikestraat 29 , Zernikestraat 29
5612 HZ
Eindhoven
The Netherlands |
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Telephone:
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+31 (0)40 2971616 |
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Email:
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c.vd.hurk@ikz.nl |
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Affiliation:
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Name:
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Corina
Hurk, van den |
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Address:
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Integraal Kankercentrum Zuid, sector onderzoek,
Zernikestraat 29 , Zernikestraat 29
5612 HZ
Eindhoven
The Netherlands |
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Telephone:
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+31 (0)40 2971616 |
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Email:
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c.vd.hurk@ikz.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Intravenous administered docetaxel regimes;
2. Age 18 years or more;
3. Written informed consent.
Exclusion criteria: 1. Boldness before the start of the study;
2. Heamatological malignancies with generalized haematogenic metastases (e.g. lymphoma, leukemia 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. Cryoglobulinemia;
7. Cryofibrinogenemia.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Hair loss
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Intervention(s)
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Scalp cooling with various cooling times or cooling temperatures.
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Primary Outcome(s)
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Efficacy and patient acceptability of scalp cooling.
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Secondary Outcome(s)
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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;
4. type of hair (determined by race).
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Secondary ID(s)
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ISRCTN00283877
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N/A
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Source(s) of Monetary Support
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Sanofi-Aventis, Integraal Kankercentrum Zuid, Interzol, Private gifts, Stichting Mitialto, Stichting Ondersteuning Regionale Kankerzorg Zuid, VGZ Eindhoven, Wetenschappelijk fonds Catharinaziekenhuis Eindhoven
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