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Mechanisms of Scalp Cooling During Chemotherapy


- candidate number10297
- NTR NumberNTR3082
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2011
- Secondary IDsM011-013 METC Noord-Holland
- Public TitleMechanisms of Scalp Cooling During Chemotherapy
- Scientific TitleMechanisms of Scalp Cooling During Chemotherapy
- ACRONYMMOSCOU
- hypothesisSkin temperature can possibly affect the effect of scalp cooling. The primary objective is to search for the possible relation between hair loss and the obtained scalp skin temperature with scalp cooling at a standard temperature.
- Healt Condition(s) or Problem(s) studiedAlopecia, Chemotherapy, Temperature, Scalp cooling
- 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 90-100 mg/m2 at 3-weekly intervals or Adriamycin-Cyclophosphamide (AC) (adryamycin at a dose of 60 mg/m2;
5. Subsequent chemotherapy consisting of decetaxel or paclitaxel is allowed after three cycles of FEC or AC.
- Exclusion criteria1. Clinical signs of scalp metastases;
2. Cold sensitivity;
3. Cold agglutinin disease;
4. Cryoglobulinemia;
5. Cryofibrinogenemia;
6. Cold posttraumatic dystrophy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2011
- planned closingdate1-nov-2011
- Target number of participants30
- InterventionsN/A
- Primary outcomeHair loss will be the primary outcome variable. 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 a 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 summaryIn cancer patients chemotherapy-induced alopecia remains one of the most frequently encountered side-effects of treatment. Scalp cooling is often an effective method to prevent chemotherapy-induced hair loss. Skin temperature, skin perfusion, drug exposure and scalp cooling time may contribute and have to be taken into account in improving the protocol for scalp cooling during administration of chemotherapy.
The primary objective of this study is to search for the possible relation between hair loss and the obtained scalp skin temperature with cooling at a standard temperature. A secondary objective is to identify a temperature cut-off score under which alopecia can be prevented by scalp cooling.
- Main changes (audit trail)
- RECORD1-sep-2011 - 19-feb-2017


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