During 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…
ID
Bron
Verkorte titel
Aandoening
breast cancer
paclitaxel
cold cap
pharmacokinetics
Ondersteuning
Erasmus MC Cancer Institute
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Difference in clearance of paclitaxel between patients who underwent scalp cooling and patients who did not use scalp cooling.
Achtergrond van het onderzoek
Chemotherapy 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.
Doel van het onderzoek
During 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.
Onderzoeksopzet
not applicable
Onderzoeksproduct en/of interventie
not applicable
Publiek
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
Wetenschappelijk
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• histologically confirmed breast cancer and planned treatment with weekly paclitaxel
• advanced disease
• written informed consent
• age ≥ 18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• baldness prior to treatment of the study
• serious psychiatric illness, confusion or intellectual disability
• cold sensitivity, cold agglutinin disease, cryoglobulinemia, cold post-traumatic dystrophy
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5543 |
| NTR-old | NTR5663 |
| Ander register | METC : 2015-140 |