| - candidate number | 1133 |
| - NTR Number | NTR90 |
| - ISRCTN | ISRCTN00283877 |
| - Date ISRCTN created | 12-sep-2005 |
| - date ISRCTN requested | 18-aug-2005 |
| - Date Registered NTR | 12-jul-2005 |
| - Secondary IDs | N/A |
| - Public Title | A multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss. |
| - Scientific Title | A multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss. |
| - ACRONYM | SCALP |
| - hypothesis | N/A |
| - Healt Condition(s) or Problem(s) studied | Hair loss |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | [default] |
| - Studytype | intervention |
| - planned startdate | 3-aug-2005 |
| - planned closingdate | 31-dec-2008 |
| - Target number of participants | 260 |
| - Interventions | Scalp cooling with various cooling times or cooling temperatures. |
| - Primary outcome | Efficacy and patient acceptability of scalp cooling. |
| - Secondary outcome | 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). |
| - Timepoints | |
| - Trial web site | http://www.geefhaareenkans.info |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Drs. Corina Hurk, van den |
| - CONTACT for SCIENTIFIC QUERIES | Drs. 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 |
| - Publications | N/A |
| - Brief summary | N/A |
| - Main changes (audit trail) | |
| - RECORD | 12-jul-2005 - 1-apr-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl