Evaluate the effectiveness of 45- and 20-minutes post-infusion cooling time for scalp cooling in patients treated with paclitaxel in comparison with the standard post-infusion cooling time of 90-minutes
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the efficacy of scalp cooling in patients treated with
paclitaxel-containing chemotherapy with a 45- and 20-minutes post-infusion
cooling time, in comparison with the standard 90 minutes and no scalp cooling,
defined by the patient*s self-determined need to wear a wig or other head
covering
Secondary outcome
* To determine the degree of chemotherapy-induced alopecia (CIA), assessed with
the Dean scale for assessment of hair loss
* To determine the grade of alopecia according to NCI CTCAE toxicity version
4.03
* To determine the tolerance of scalp cooling, assessed by a (self-adapted)
visual analogue scale (VAS) of 0-10, in which 0 represented *not tolerable at
all* and 10 meant *very tolerable*
* To determine the added value of scalp cooling for weekly paclitaxel; what is
the incidence of severe alopecia with and without scalp cooling
* Compare the quality of life in patients who underwent scalp cooling versus
those who did not and in patients with hair loss despite scalp cooling versus
those with no hair loss, assed with the chemotherapy-induced alopecia distress
scale (CADS)
Background summary
Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects
for patients. Scalp cooling can prevent or minimise CIA in approximately half
of all patients, depending on many factors, e.g. type and dosage of
chemotherapy. High rates of success are seen in patients treated with taxanes,
up to 80-90%. Previous research has shown comparable results of scalp cooling
in docetaxel-treated patients when shortening the post-infusion cooling time
(PICT) from the initial standard of 90 minutes to 45- and 20 minutes. A shorter
PICT is an advantage for both the patient, who can spend less time in the
hospital, as well for the logistics at oncological departments. Paclitaxel and
docetaxel are both classical taxanes, thatwho share similar mechanisms of
action and have comparable plasma terminal half-life times, therefore it seems
plausible that the PICT can be shortened for paclitaxel-treated patients as
well.
Study objective
Evaluate the effectiveness of 45- and 20-minutes post-infusion cooling time for
scalp cooling in patients treated with paclitaxel in comparison with the
standard post-infusion cooling time of 90-minutes
Study design
The study is a prospective, multicenter trial, in which consecutively a PICT of
45- and 20 minutes will be investigated in patients treated with paclitaxel.
Patients who chooses scalp cooling will be randomly assigned to a treatment arm
of 45- or 20-minutes PICT. If the patient does not want scalp cooling, the
patient will be asked for the control group to determine the incidence of
paclitaxel-induced alopecia.
The results from a PICT of 45- and 20-minutes will be compared with the
standard PICT of 90-minutes, using previous collected data from the Dutch Scalp
Cooling Registry. In which 377 patients are registered who received weekly
paclitaxel and underwent scalp cooling with a PICT of 90 minutes.
Intervention
Randomisation between a 45- and 20-minutes post-infusion cooling time
Study burden and risks
Scalp cooling is nowadays a non-experimental, and frequently used, supportive
care intervention in Dutch hospitals. Previous research showed that scalp
cooling is safe and well tolerable. Shortening the post-infusion cooling time,
the experimental factor in our study, is not associated with an additional risk
for patients. There is at the most, a slightly increased chance of CIA, which
can lead to psychological discomfort. The questionnaires which have to be
filled in each cycle of chemotherapy take about 5 minutes to complete. All
scalp cooled patients who participate in this study will benefit from a shorter
stay on the chemotherapy ward. Non-scalp cooled patients will not have any
advantage, neither disadvantage.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
* Patients receiving weekly-administered paclitaxel-containing chemotherapy (minimal of 3 planned administrations) in a dose of 80-90 mg/m2
o Paclitaxel monotherapy
o Paclitaxel in combination with carboplatin
o Paclitaxel in combination with monoclonal antibodies:
* Bevacizumab
* Trastuzumab
* Age * 18 years
* WHO performance status 0-2
* Survival expectation must be > 3 months
* Written informed consent according to the local Ethics Committee requirements
Exclusion criteria
* Treatment with paclitaxel in sequential schemes with other alopecia inducing agents such as (paclitaxel monotherapy after adriamycin, cyclophosphamide (AC) or paclitaxel monotherapy after 5-fluouracil, epirubicin, cyclophosphamide (FEC) treatment)
* Alopecia before the start of the study
* Rare cold-related disorders, like:
o Cold sensitivity
o Cold agglutinin disease
o Cryoglobulinaemia
o Cryofibrinogenaemia
o Cold posttraumatic dystrophy
Design
Recruitment
metc-ldd@lumc.nl
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 | NL61964.058.17 |