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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44910
Enrollment
14
Registered
2017-09-29
Start date
2016-02-05
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

advanced carcinoma

Interventions

pharmacokinetics
paclitaxel

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Difference in pharmacokinetics of paclitaxel (AUC, e.g. the exposure to paclitaxel in blood) between patients who undergo scalp cooling during their anti-cancer treatment versus those patients, who did not undergo scalp cooling during their anti-cancer treatment

Secondary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)