Effects of scalp cooling on pharmacokinetics of paclitaxel in women treated for advanced breast cancer
Completed
- Conditions
- breast cancerpaclitaxel cold cappharmacokinetics
- Registration Number
- NL-OMON20523
- Lead Sponsor
- Department of Medical Oncology, Erasmus MC Cancer Institute
- Brief Summary
after study results are present
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
Inclusion Criteria
• histologically confirmed breast cancer and planned treatment with weekly paclitaxel
• advanced disease
Exclusion Criteria
• baldness prior to treatment of the study
• serious psychiatric illness, confusion or intellectual disability
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in clearance of paclitaxel between patients who underwent scalp cooling and patients who did not use scalp cooling.
- Secondary Outcome Measures
Name Time Method 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