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Effects of scalp cooling on pharmacokinetics of paclitaxel in women treated for advanced breast cancer


- candidate number23639
- NTR NumberNTR5663
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jan-2016
- Secondary IDs2015-140 METC
- Public TitleEffects of scalp cooling on pharmacokinetics of paclitaxel in women treated for advanced breast cancer
- Scientific TitleEffects of scalp cooling on pharmacokinetics of paclitaxel in women treated for advanced breast cancer
- ACRONYMPK paclitaxel cold cap
- hypothesisDuring the cooling by a cold cap, the scalp is cooled to 4oC for a long period of time (30 minutes prior to start and up to 45 minutes after the infusion of paclitaxel). This could be of influence on the body temperature. Pharmacokinetics and pharmacodynamics of several drugs have shown to be influenced by body temperature. We hypothesized that there is no difference in pharmacokinetics of paclitaxel between patients who are treated with weekly paclitaxel with and without using scalp cooling.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Pharmacokinetics
- Inclusion criteria histologically confirmed breast cancer and planned treatment with weekly paclitaxel
advanced disease
written informed consent
age ≥ 18 years
- Exclusion criteria baldness prior to treatment of the study
serious psychiatric illness, confusion or intellectual disability
cold sensitivity, cold agglutinin disease, cryoglobulinemia, cold post-traumatic dystrophy
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 25-jan-2016
- planned closingdate
- Target number of participants23
- Interventionsnot applicable
- Primary outcomeDifference in clearance of paclitaxel between patients who underwent scalp cooling and patients who did not use scalp cooling.
- Secondary outcomeDifference of paclitaxel levels in plasma between patients who are treated with weekly paclitaxel and using scalp cooling developing alopecia vs those who did not develop alopecia according to CTCAE 4.03 toxicity criteria
- Timepointsnot applicable
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. A. Jager
- CONTACT for SCIENTIFIC QUERIESMD PhD Ron H.J. Mathijssen
- Sponsor/Initiator Erasmus MC Cancer Institute, department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Cool Singel stichting
- Publicationsafter study results are present
- Brief summaryChemotherapy induced hair loss is a feared side effect of cancer treatment. Scalp cooling during the administration of cytotoxic drugs can reduce this hair loss. It is currently often used by breast cancer patients and can prevent severe alopecia, depending on the type of cytotoxic drug that is used. During the cooling, the scalp is cooled to 4oC for a long period of time (30 minutes prior to start and up to 45 minutes after the infusion of paclitaxel). This could be of influence on the body temperature. Pharmacokinetics and pharmacodynamics of several drugs are influenced by body temperature [1] Despite its frequent use, it is unknown what the effect of scalp cooling is on the pharmacokinetics and dynamics of the cytotoxic drugs that are infused. This is of clinical relevance, as a change in pharmacokinetics or pharmacodynamics could lead to under- or overdosing. Therefore, in the current study we will measure levels of paclitaxel in plasma of patients who were cooled during the administration of cytotoxic drugs compared to patients who were not cooled.
- Main changes (audit trail)
- RECORD22-jan-2016 - 12-feb-2017


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