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van CCT (UK)


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van CCT (UK)


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


- candidate number1133
- NTR NumberNTR90
- ISRCTNISRCTN00283877
- Date ISRCTN created12-sep-2005
- date ISRCTN requested18-aug-2005
- Date Registered NTR12-jul-2005
- Secondary IDsN/A 
- Public TitleA multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss.
- Scientific TitleA multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss.
- ACRONYMSCALP
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedHair loss
- Inclusion criteria1. Intravenous administered docetaxel regimes;
2. Age 18 years or more;
3. Written informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 3-aug-2005
- planned closingdate31-dec-2008
- Target number of participants260
- InterventionsScalp cooling with various cooling times or cooling temperatures.
- Primary outcomeEfficacy and patient acceptability of scalp cooling.
- Secondary outcomeRelation 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).
- Timepoints
- Trial web sitehttp://www.geefhaareenkans.info
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. Corina Hurk, van den
- CONTACT for SCIENTIFIC QUERIESDrs. Corina Hurk, van den
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Sanofi-Aventis, Integraal Kankercentrum Zuid, Interzol, Private gifts, Stichting Mitialto, Stichting Ondersteuning Regionale Kankerzorg Zuid, VGZ Eindhoven, Wetenschappelijk fonds Catharinaziekenhuis Eindhoven
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD12-jul-2005 - 1-apr-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl