search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


A study of scalp skin temperature during scalp cooling in patients treated with chemotherapy.


- candidate number8087
- NTR NumberNTR2339
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mei-2010
- Secondary IDsM010-010 METC Noord-Holland
- Public TitleA study of scalp skin temperature during scalp cooling in patients treated with chemotherapy.
- Scientific TitleA study of scalp skin temperature during scalp cooling in patients treated with chemotherapy.
- ACRONYMFECTemp
- hypothesisSkin temperature can possibly affect the effect of scalp cooling. First a pilot study will be conducted to check the feasibility of the main study. The primary objective of the main study is to identify a cut-off score under which alopecia can be prevented by scalp cooling.
- Healt Condition(s) or Problem(s) studiedTemperature, Alopecia, Scalp cooling, FEC chemotherapy
- Inclusion criteria1. Patients with breast cancer;
2. Age 18 years or more;
3. Written informed consent;
4. Indication for three to six cycles of intravenous administered 5-Fluorouracil-Epirubicin-Cyclophosphamide (FEC) regimen with an epirubicine dose of 90 mg/m2 or more at 3-weekly intervals.
- Exclusion criteria1. Boldness before the start of the study;
2. Clinical signs of scalp metastases;
3. Cold sensitivity;
4. Cold agglutinin disease;
5. Cryoglobulinemia;
6. Cryofibrinogenemia;
7. Cold posttraumatic dystrophy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2010
- planned closingdate1-mei-2011
- Target number of participants12
- InterventionsN/A
- Primary outcomeThe pilot study will check the feasibility of the main study, after which specific parameters/outcomes will be defined. Hair loss will be measured asking the patient whether or not a wig or head cover is required, using the World Health Organisation (WHO) grading system and a visual analogue scale (VAS), making pictures and using the trichometer (a diagnostic instrument for measuring changes in hair quantity (mass), hair diameter, and hair density).
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMSc. M.M.C. Komen
- CONTACT for SCIENTIFIC QUERIESMSc. M.M.C. Komen
- Sponsor/Initiator Medisch Centrum Alkmaar
- Funding
(Source(s) of Monetary or Material Support)
Foreest Institute Alkmaar, Medisch Centrum Alkmaar
- PublicationsN/A
- Brief summaryThe primary aim of this study is to assess variations in scalp skin temperature between patients during scalp cooling in the high dose FEC-regimen, thereby improving the results of scalp cooling in the high dose 5Fluorouracil-Epirubicin-Cyclophosphamide (FEC) regimen.
- Main changes (audit trail)
- RECORD26-mei-2010 - 2-sep-2011


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