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van CCT (UK)


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van CCT (UK)


A study to determine the effect of post-infusion cooling time in the high dose FEC-regimen.


- candidate number2088
- NTR NumberNTR680
- ISRCTNISRCTN97879847
- Date ISRCTN created21-jul-2006
- date ISRCTN requested19-jul-2006
- Date Registered NTR11-mei-2006
- Secondary IDs
- Public TitleA study to determine the effect of post-infusion cooling time in the high dose FEC-regimen.
- Scientific TitleA study to determine the effect of post-infusion cooling time in the high dose FEC-regimen.
- ACRONYMPOSTFEC
- hypothesis20 to 30% improvement of scalp cooling results due to longer post-infusion cooling times.
- Healt Condition(s) or Problem(s) studiedHair loss, Breast cancer
- Inclusion criteria1. Intravenous administered FEC-regimen with an epirubicine dose of 90 mg/m2 or more at 3-weekly intervals; 2. Age 18 years or more; 3. Written informed consent.
- Exclusion criteria1. Boldness before the start of the study; 2. Hematological malignancies with generalized haematogenic metastases and if in those conditions chemotherapy is given with a curative intent; 3. Clinical signs of sclap metastases.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jun-2006
- planned closingdate31-dec-2008
- Target number of participants130
- InterventionsRandomly assigned post-infusion cooling time of 90 or 150 minutes.
- Primary outcomeAmount of hair loss.
- Secondary outcome1. Acceptability of scalp cooling; 2. Relation of the efficacy of scalp cooling with prior chemotherapy/radiotherapy or hormonal treatment, liver- or kidney function disorder and type of hair; 3. Quality Of Life during chemotherapy.
- 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 Medisch Centrum Alkmaar
- Funding
(Source(s) of Monetary or Material Support)
Integraal Kankercentrum Zuid, Interzol, Stichting Mitialto, Stichting Ondersteuning Regionale Kankerzorg Zuid
- PublicationsN/A
- Brief summaryThe primary aim of current study is to assess the effect of different cooling times on the efficacy of scalp cooling, thereby mproving the results of scalp cooling in the high dose 5-Fluorouracil - Epirubicin - Cyclophosphamide (FEC) regimen.
- Main changes (audit trail)
- RECORD11-mei-2006 - 1-apr-2009


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