To study whether the pharmacokinetics of paclitaxel are influenced by scalp cooling
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
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, with a good chance of success depending on the type of chemotherapy that
is used. For the cytotoxic drug paclitaxel it is often successful. Although
scalp cooling is regularly used, it is unknown whether scalp cooling has
effects on the concentration of chemotherapy in the blood. In this project, we
will study the effect of scalp cooling on the concentration of paclitaxel in
blood.
Study objective
To study whether the pharmacokinetics of paclitaxel are influenced by scalp
cooling
Study design
36 patient have to be enrolled in this trial to have sufficient power for the
primary endpoint (18 controls and 18 who undergo scalp cooling). The
control-group exists of 25 patients, that means we have to enroll 14 patients
who undergo scalp cooling to maintain power. The data from the control-group
are already available from a previous trial.
During the administration of paclitaxel and the use of scalp cooling,
pharmacokinetics will be measured during 1 day. If a patient stops with scalp
cooling during their anti-cancer treatment, pharmacokinetics will be measured
again in the case a patient gives permission to do so.
Study burden and risks
Patients will stay 6 hours longer at the outpatient clinic during one
paclitaxel cycle. During this period blood withdrawals for pharmacokinetic
purposes will be performed, which are accompanied by a negligible risk of
bleeding or infection.
Groene Hilledijk 301
Rotterdam 3075 EA
NL
Groene Hilledijk 301
Rotterdam 3075 EA
NL
Listed location countries
Age
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
Design
Recruitment
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 |
|---|---|
| CCMO | NL52136.078.15 |