No registrations found.
ID
Source
Brief title
Health condition
breast cancer
paclitaxel
cold cap
pharmacokinetics
Sponsors and support
Erasmus MC Cancer Institute
Intervention
Outcome measures
Primary outcome
Difference in clearance of paclitaxel between patients who underwent scalp cooling and patients who did not use scalp cooling.
Secondary outcome
Difference 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
Background summary
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.
Study objective
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.
Study design
not applicable
Intervention
not applicable
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
A. Jager
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
Tel 010 704 17 33
a.jager@erasmusmc.nl
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5543 |
| NTR-old | NTR5663 |
| Other | METC : 2015-140 |