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

Completed

• Conditions: advanced carcinoma; 10027655

• Registration Number: NL-OMON44910
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

Histologically confirmed metastasized cancer and planned treatment with weekly paclitaxel
Women
Written informed consent
Age >= 18 years

Exclusion Criteria

Boldness prior to treatment of the study
Serious psychiatric illness, confusion or intellectual disability
Hematologic malignancy
Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cold post-traumatic dystrophy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in pharmacokinetics of paclitaxel (AUC, e.g. the exposure to<br /><br>paclitaxel in blood) between patients who undergo scalp cooling during their<br /><br>anti-cancer treatment versus those patients, who did not undergo scalp cooling<br /><br>during their anti-cancer treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Difference in pharmacokinetics of paclitaxel (AUC, e.g. the exposure to<br /><br>paclitaxel in blood) between patients who do and who do not develop boldness<br /><br>during the use of scalp cooling and their anti-cancer treatment. If this is<br /><br>clinically relevant, other pharmacokinetic parameters will be studied, such as<br /><br>clearance.</p><br>