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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20523

Enrollment

Registered

2016-01-22

Start date

2016-01-25

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer paclitaxel cold cap pharmacokinetics

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • histologically confirmed breast cancer and planned treatment with weekly paclitaxel • advanced disease • written informed consent • age ≥ 18 years

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Difference in clearance of paclitaxel between patients who underwent scalp cooling and patients who did not use scalp cooling.	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactA. Jager

Erasmus MC, Room 471

a.jager@erasmusmc.nlTel 010 704 17 33

Outcome results